COMPARATIVE ESTIMATION OF PIPERINE IN AYURVEDIC LOZENGES BY UV SPECTROSCOPIC METHOD.

ISBN: 978-81-85694-67-2

Abstract

Ayurvedic lozenges are immensely popular in today’s world, because due to its highly palatable taste, cheap, soothing effect, counter-irritant effect, decreasing abdominal flatulence, and treating Anorexia. Herbs of Piper species are one of the most important ingredients of Ayurvedic lozenges and Piperine is the main chemical constituent of herbs of Piper species. In the present study an attempt was made for the estimation of piperine in ayurvedic lozenges sample by using UV-spectrophotometer. Three samples of lozenges from different reputed brand have been selected for this purpose. The amount of piperine in three samples (S-1, S-2, and S-3) was found to be 1.55, 1.36 and 1.40 µg/ml respectively. Recovery studies were carried out by standard addition method and the average % recovery of the three samples S-1, S-2, S-3 were found to be 98.62%, 99.32%, and 98.35% respectively.

Introduction

Lozenges are small, medicated candy intended to be dissolved slowly in the mouth to lubricate and soothe irritated tissues of the throat and also have carminative effect. Several ayurvedic companies come forward in today’s FMCG field to market throat lozenges, and carminative digestive lozenges. Trikatu^[1-3] is an important ayurvedic formulation, which have synergistic effect, and is used in several classical anti-tussive, expectorant^[2] preparation and also to fight, acidity^[3] and anorexia. Trikatu consists of Piper longum, Piper nigrum and Zingiber officinalis^[4]. Piperine is an important heterocyclic alkaloid of pyridine and piperidine skeletal structures ^[4] found in the herbs of Piper species. These herbs enhanced the activities of antioxidant enzymes--superoxide dismutase, catalase, glutathione reductase and glutathione-S-transferase in both gastric and intestinal mucosa, suggesting a gastrointestinal protective role which is the main responsible factor for the therapeutic effect of these ayurvedic lozenges. Apart from the classical use, recent study has proved that Piperine have antidepressant activity ^[5-6], anti-inflammatory activity^[7], gastro protective effect^[8-9], immune-modulator effect^[10], bioavailability enhancer^[11] etc. Hence the amount of piperine in this type of lozenges may be a parameter, to determine the quality of ayurvedic lozenges. In the present study a comparative evaluation of the three most popular branded ayurvedic lozenges on the basis of Piperine content.

MOLECULAR Wt	285.342
MOLECULAR FORMULA-	C17H19NO3

Materials and methods

Gift sample of Piperine standard was taken from Merck chemicals, India. Ayurvedic lozenges from three different brands were collected from local vendor, and named them as S-1, S-2 and S-3. UV absorbance was recorded using “Varian UV- Spectrophotometer” with Carry-100 software.

Preparation of standard solution for calibration curve of ciprofloxacin

Stock solution of Piperine was prepared by dissolving 0.01gram in 10 ml of methanol. Standard solutions were prepared from stock solution in the range of 2 to 20 µg/ml in methanol. The absorbance of piperine was measured at 342 nm (λ_max for piperine) against water as blank. Mean of three readings were taken for each standard solutions. Calibration curve was plotted between absorbance and concentration. 

Table1: Standard curve of Piperine

Standard	Conc. (µg/ml)	Mean*	SD	%RSD
Std. 1	0.0	0.0005	0.0007	>100
Std. 2	2.0	0.1150	0.0003	0.26
Std. 3	4.0	0.2375	0.0006	0.24
Std. 4	8.0	0.5258	0.0007	0.13
Std. 5	12.0	0.8425	0.0000	0.00
Std. 6	16.0	1.1795	0.0004	0.03
Std. 7	20.0	1.5454	0.0006	0.04

   *Value expressed as mean of three readings

Preparation of sample solution

Five lozenges of S-1 were taken in a mortar and pestle, and powdered. The powdered sample was dissolved in the water q.s, and then chloroform is added to the water containing the dissolved sample. The bi-phasic mixture is then taken in a separating funnel and slowly shaken. The chloroform part which contains piperine is separated out, the chloroform is evaporated in water bath, and TLC is carried out with the piperine extract, for its conformation, with the application of standard Piperine spot, on the same plate. Then methanol is added to the piperine extract, and the solution is diluted. The mobile phase is made up of chloroform and methanol in the ratio of (95:5), the absorbance of sample solutions was measured at 342 nm against methanol as blank. Mean of three readings were taken for each sample solutions, the process was repeated with the sample, S-2 and S-3.   

   

Sample	Conc. (µg/ml)*	SD	%RSD
S1	1.55	0.0003	0.24
S2	1.36	0.0002	0.19
S3	1.40	0.0002	0.21

Results and discussion.

This method involves the measurement of UV absorbance at 342 nm for piperine corresponding to the absorption maxima. The absorbance characteristics showed that piperine obeys Beer’s Lambert law within the concentration range from 2-20 µg/ml at the λ_max 342 nm. Calibration equation for this method was found to be Abs = 0.07733*Concentration, with Correlation Coefficient is of 0.99569.                                                               

Recovery Studies were carried out by standard addition method & the average % recovery of the four samples S1, S2 and S3 were found to be 98.62%, 99.32% and 98.35 % respectively. Results obtain from the recovery study indicating the accuracy & the precision of the method.

Conclusion

The developed method was found to be accurate & simple. We came to know that all the three samples of lozenges from different manufacturers contains considerably amount of piperine, and thus they bear the necessary quality, for therapeutic efficacy.

References

1. Kaviraj Kunjalal Bhisagratna. Susruta Samhita , 38/58-19, Chowkhamba Sanskrit Series Office. Third Edition. 2005

2. K.R. Srikantha Murthy. Bhavaprakasa of Bhavamisra . Chowkhamba Sanskrit Office.

3. S. Suresh Babu .Yoga Ratnākara. Chowkhamba Sanskrit Series Office. Third Edition

4.Trease & Evans. Pharmacognosy. Elsevier publication.Fifteenth edition, p 335

5. Pal A, Nayak S, Sahu PK, Swain. Piperine protects epilepsy associated depression. A study on role of monoamines. Eur Rev Med Pharmacol Sci 2011; 15(11):1288-95

6. Mao QQ, Huang Z, Ip SP, Xian YF, Che CT. Role of 5-HT(1A) and 5-HT(1B) receptors in the antidepressant-like effect of piperine in the forced swim test. Neurosci Lett. 2011;504(2):181-4.

7. Sabina EP, Nagar S, Rasool. M.A role of piperine on monosodium urate crystal-induced inflammation--an experimental model of gouty arthritis.Inflammation 2011 Jun;34(3):184-92.

8. Prakash UN, Srinivasan K. Gastrointestinal protective effect of dietary spices during ethanol-induced oxidant stress in experimental rats.Appl Physiol Nutr Metab 2010 Apr;35(2):134-41

9.Ramakrishna Rao R, Platel K, Srinivasan K. In vitro influence of spices and spice-active principles on digestive enzymes of rat pancreas and small intestine. Nahrung 2003 Dec;47(6):408-12.

10.Pathak N, Khandelwal S. Immunomodulatory role of piperine in cadmium induced thymic atrophy and splenomegaly in mice.Environ Toxicol Pharmacol  2009 Jul;28(1):52-60

11.Atal CK, Dubey RK, Singh J. Biochemical basis of enhanced drug bioavailability by piperine: evidence that piperine is a potent inhibitor of drug metabolism. J. Pharmacol. Exp. Ther; 232(1): 258–62. 

A REVIEW ON CURRENT TRENDS IN PHARMACEUTICAL MARKETING OF AYURVEDIC DRUGS

ISBN NO.- 978-93-81212-11-0

ABSTRACT:
The pharmaceutical industry is the world’s largest industry due to worldwide revenues of approximately US$2.8 trillion. Ayurvedic Pharma companies have some little contribution to that but it is very important, & growing very faster too. Now a days, & in recent future Herbal/Ayurvedic companies will take a very big part in the pharma industry. India played a major role in that area. Many countries from Asia, like Chaina, Japan etc. are also leading contributors. USA, Europe are playes roles mostly as consumers. However the marketing of those products are also important. Because marketing is the key for any pharma company for growing & achieving the desired success. So for that different companies adopt different strategies & implement them on practical field.

1.Introduction:
Indian Pharmaceutical Industry is poised for high consistent growth over the next few years, driven by a multitude of factors. Top Indian Companies like Ranbaxy, DRL CIPLA, Himalaya and Dabur have already established their presence.
The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta.

2. Transforming Ayurveda1
The Indian Ayurvedic industry is re-packaging the Traditional healing principles into a modern avatar. Before the evolution of Indian Ayurveda into an industry, the practice of Ayurveda was confined to physicians and was considered more of a service than a profession

3. Pharma Marketing Process and its Challenges2
Many pharmaceutical companies have successfully deployed plethora of strategies. Use of medical representatives for marketing products to physicians and to exert some influence over others in the hierarchy of decision makers has been a time-tested tradition. Typically, sales force expense comprises an estimated 15-20% of annual product revenues, the largest line item on the balance sheet.
Most Prominent Performance Related Issues:

a) Increased competition and shortened window of opportunity.
b) The number and the quality of medical representatives
c) Very high territory development costs.
d) High training and re-training costs of sales personnel.
e) Busy doctors giving less time for sales calls.
f) Poor territory knowledge in terms of business value at medical representative.

4. Pharmaceutical Company Business Strategies3
What’s the secret behind these successes? For one, the company operates in niche formulations (chronic) segments such as psychiatry, cardiovascular, gastroentology and neurology. While most of the top Indian companies have focused on antibiotics and anti– infective (acute), Sun Pharma focused on therapeutic areas such as depression, hypertension and cancer. Two models are described for the business strategies of pharmaceutical companies.

4.1 Marketing approaches of Super Core Model
In pharmaceutical market there has been a significant shift from Acute towards Chronic Therapy area. Chronic segments are driving the growth of the market. This is evident from high growth rates achieved by firms like Sun Pharma, Dr.Reddy laboratories and Dabur Pharma Ltd.
Pharmaceutical companies are competing with one another, and might adopt a new sales strategy. For example, sometimes in the same geographical area there are five representatives for just one company, or different representatives for the same drug in different settings. As a result the aggressiveness of representatives has also been increasing. Therefore, they tend to have more frequent visits to encourage doctors to prescribe drugs and thus increase sales.

4.2 Marketing approaches of Core Model
In present scenario companies are focusing more and more on the availability of products so as to enjoy good image in their cutomer’s (doctors) chamber. Many companies such as Glaxo, Pfizer, Dabur, FDC, Aventies, Cipla etc. are known for their availability of products.
It has been observed that sometimes there are more than fifteen or sixteen representatives in a day are meeting with their customer and requesting for same type of products.

5. Global Market4
Total global herbal market is of size 62.0 billion dollars, in this India’s contribution is only one billion dollars. European union is the biggest market with the share 45% of total herbal market. North America accounts for 11%, Japan 16%, Asian countries 19% and rest of European Union 4.1%. Countries like Japan and China have successfully marketed their traditional medicines abroad.
When compared to the Chinese and the Japanese level of penetration in the global market India is not at all figuring anywhere. India has 16 Agro-climatic zones, 10 vegetative zones, 15 biotic provinces, 426 biomes, 45000 different plant species and 15000 medicinal plants that include 7000 ayurveda, 700 in Unani medicine, 600 in Siddha medicine and 30 in modern medicine. This makes India one among 12 mega biodiverse countries of the world, which despite having only 2.5 % total land area, accounting for over 8 % of the recorded species of the world. The forecast is that the global market for herbal products is expected to be $5 Trillion by 2050.

6. Regulatory Status of Herbal Medicine Worldwide5
The World Health Organization (WHO) estimates that 4 billion people—80 percent of the world population--use herbal medicine for some aspect of primary health care. Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in
Ayurvedic, Homeopathic, Naturopathic, traditional oriental and Native American Indian medicine.

6.1 Europe
Drug approval considerations for phytomedicines (medicines from plants) in Europe are the same as those for new drugs in the United States, where drugs are documented for safety, effectiveness, and quality.

6.1.1 France
where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. These products are distinguished from approved pharmaceutical drugs by labels stating "Traditionally used for . . .".

6.1.2 Germany
In Germany there is a further distinction between "prescription-only drugs" and "normal prescription drugs." The formers are available only by prescription.

6.1.3 England
England generally follows the rule of prior use, which says that hundreds of years of use with apparent positive effects and no evidence of detrimental side effects are enough evidence that the product is safe.

6.2 Asia:
In more developed Asian countries such as Japan, China, and India, "patent" herbal remedies are composed of dried and powdered of herbs or herb extracts in liquid or tablet form. Liquid extracts are used directly in the form of medicinal syrups, tinctures, cordials, and wines.

6.2.1 China: In China, traditional herbal remedies are still the backbone of medicine. Use varies with region, but most herbs are available throughout China. Until 1984 there was virtually no regulation of pharmaceuticals or herbal preparations. In 1984, the People's Republic implemented the Drug Administration Law.

6.2.2 Japan:
Traditional Japanese medicine, called ‘Kampo’, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese Folklore. Today 42.7 percent of Japan's Western-trained medical practitioners prescribe Kampo medicines, and Japanese national health insurance pays for these medicines.

7. THE AYURVEDIC MEDICINE INDUSTRY IN INDIA6
Ayurvedic medicines are produced by several thousand companies in India. The industry has been dominated by less than a dozen major companies for decades.The key suppliers in Ayurveda are Dabur, Baidyanath, and Zandu, which together have about 85% of India's domestic market.
Dabur India Ltd. is India's largest Ayurvedic medicine supplier and the fourth largest producer of FMCG. It was established in 1884, and had grown to a business level in 2003 of about 650 million dollars per year, though only a fraction of that is involved with Ayurvedic medicine.
Sri Baidyanath Ayurvedic Bhawan Ltd. was founded in 1917 in Calcutta, and specializes in Ayurvedic medicines, though it has recently expanded into the FMCG sector. Baidyanath has a sales volume of about 350 million dollars. The company reports having over 700 Ayurvedic products.
Zandu Pharmaceutical Works was incorporated in Bombay in 1919. The company focuses primarily on Ayurvedic products. Today its total sales volume is about 45 million dollars. One of its current projects is to develop a dopamine drug from a plant extract.
The Himalaya Drug Company was established in 1934 in Bangalore. It currently has a business of about 500 million dollars. It is known in the U.S. for the product Liv-52, marketed as a liver protector.
Charak Pharmaceuticals was founded in 1947, and currently has three distribution centers in India. It has gained a large advantage with its new product Evanova.
Vicco Laboratories was established in 1958. It is best known internationally for its toothpaste product, Vajradanti, which has been marketed in the U.S. for more than 25 years.
The Emami Group founded in 1974, provides a diverse range of products, doing 110 million dollars of business annually. The parts, himani & Zandu prepare Ayurvedic preparations.
Aimil Pharmaceuticals Ltd. incorporated in 1984 and engaged in manufacturing and sale of both generic and proprietary Ayurvedic medicines, with a business level of about 20 million dollars annually. It was honored by the Indian Government's National Award for Quality Herbal Preparations and National Award for R & D in the year 2002.


8. STATUS OF AYURVEDA IN INDIA7
The statistics on the Ayurvedic system in India and these data about the manpower and institutional aspects of Ayurveda have emerged:
• Number of registered medical practitioners: 366,812
• Number of dispensaries: 22,100
• Number of hospitals: 2,189
• Number of hospital beds: 33,145
• Number of teaching institutions (undergraduate): 187
• Number of upgraded postgraduate departments: 51
• Number of specialties in postgraduate medical training: 16
• Number of pharmacies manufacturing Ayurvedic medicines: 8,400

9.CONCLUTION
There has been a shift in universal trend from synthetic to herbal medicine recently. It is ancient wisdom that plants have therapeutic value and are used to treat various diseases since Neanderthal age. All ancient civilizations in the world are known to use plants for medicinal purposes. Ayurveda and traditional Chinese medicines are well known to the world for their natural ingredients and multiple benefits. Nature has bestowed our country with an enormous wealth of medicinal plants; therefore India has often been referred to as the Medicinal Garden of the world.
Today, people around the globe are giving preference to alternative medicines such as Ayurveda, Naturopathy, Homeopathy and Herbal Medicine. Increasing realization of the side effects of Allopathic medicines, coupled with the growing awareness about the medicinal benefits as well as therapeutic effect of herbal products is pushing up the demand for herbal extracts, dietary supplements and herbal-based beauty aids worldwide.


10.REFERENCE
1. www.expresspharmaonline.com/20080831/market01.shtml
2.searchengineland.com/getting-to-the-heart-of-things-big-pharma-marketing-challenges-12002
3. www.glgroup.com/News/Pharmaceutical-business-strategy-27029.html
4. http://www.hindu.com/2010/03/24/stories/2010032454380500.htm
5. www.who.int/medicinedocs/pdf/whozip57e/whozip57e
6. www.itmonline.org/arts/ayurind.htm
7. www.ccimindia.org/colleges_status_ayurveda_2010-11.php

My Emami Project

ACKNOWLEDGEMENT
Just a few ornamental words are not enough to pen down my feelings towards those eminent personalities who have lend their precious time, advice, & helping hands for the successful completion of my B. Pharm. Project. It is my pleasure to acknowledge them & their contribution.

First & foremost I would take the privilege to express my feelings through a humble prayers as a mark of respect for Prof. B.K. Gupta, Dr. N.C. Chaklanobish, Dr. Neene Sharma, Mr. Amitava Das, my industrial guide, who are giving me a opportunity to undergo a training at ‘Research & Development’ & ‘Production Department’ unit of the esteemed company Emami Ltd.. Their immense cognizance in the field of pharmaceutical have always ignited my zeal to pursue my work with strong determination & perseverance. Their timely criticism has served to evacuate my mistakes & thus led to materialization.

I express my immense gratitude to my college principal Prof. J.N. Pandey for providing me a chance to work in such an esteemed industry, Emami Ltd.. His suggestions both in technical & non-technical field have showed me new horizon to do something new in the industrial field.

I want to express my sincere gratitude to the company Emami Ltd. For permitting me to work in their esteemed R&D unit. I also express my thanks to Mr. Sukhendu Bikash Mondal who have always ignited me to speedup my work so that I am able to complete work within the stipulated time & every possible helps for completion of my project work.

I take great privilege to express my sincere thanks to Mr. Milindo Bhattacharya for his dedicated co-operation & support for completion of my project work.

I offer handful of thanks for assistance to Mr. Goutam Ganguli, Mr. Naba Kumar Dutta, Ms. Payel Mukharjee, Ms. Swapna Prasad inside the R&D unit; Ms. Mohua Roychowdhari, Ms. Somali Dey, Mr. Suman Sasmal, Ms. Nupur Banik inside the Q.C. unit; Mr. Prabir Aich, Mr. Tapan Porey, Mr. Shankar Gon, Mr. Sudipta , inside the Production unit; & a special thanks to Mr. Swapan Mishra.
Now it’s the time to look at my college ‘Bengal Institute of Pharmaceutical Sciences’ for providing me the chance for industrial exposure. I also thank with handful of roses to the teaching & non-teaching staffs for their educational & technical support.

I have no words to express my thanks to my most beloved parents for their continuous support & love.

I feel honored to acknowledge the vigilant support provide by my friend Satadru Palbag from the initial juncture to the final submission of my project.

At last, time has arrived to worship the eternal savior of mankind for his blessing & support & to accommodate my thesis at his lotus feet.

Any omission of names is due to inadequate remembrance or availability of space is highly regretted.


PREFACE
Navaratna oil, Boro plus, Lalima, Fast Relief, Sona Chandi Chwanprash are some products of many wonderful formulations of ‘Emami Ltd.’ It is not happened in just one day. In 1974 Mr.R.S.Agarwal & Mr.R.S.Goenka, two ordinary man give up their jobs in ‘Aditya Birla Group’ & started ‘Group Emami’ with a some of rupee 20000. After some year they take over ‘Himani Ltd.’ make producing the products of ‘Himani Ltd.’
Then they started to enjoy a big profit in their business. At 2008 they take over ‘Zandu Pharmaceutical Works Ltd.’
The group has also business interest in the field of Paper & newsprint, ball pen tips, hospital, bio diesel, edible oil, cement, real estate, & retail.
In hospital business they grow a lot. The AMRI hospital in Kolkata is one of the biggest hospital in Kolkata.
In construction field their jobs will remembering for a 100s of years. The ‘South City’ project in Kolkata is now the highest building & biggest shopping mall in Kolkata.
They also invest 500cr. In Jatropa plantation project in Oromia in Ethiopia in East Africa.
Emami Biotech currently operates an integrated plant at Haldia in West Bengal with a capacity to produce 1800 tonnes of edible oil per day & 300 tonnes of bio-diesel from palm oil.
So, Emami is the company who brings about a huge business field not only in India but also in abroad. And the Emami is a Kolkata based company, so, we have to be proud of emami.


CONTENT
1. Liquid dosage form
i. Internal
a) Himani Lalima Syrup
b) Himani Femi plus Syrup
ii. External
a) Navaratna oil

2. Churna
i. Good Morning Laxetive Churna

3. Capsule
i. Femi plus Capsule

4. Cream
i. Boro plus
ii. Fast Relief

5. TLC Profile of Boroplus.

6. Conclusion


LIQUID DOSAGE FORM
Liquid dosage form may be meant for internal or external administration. A true solution should be clean homogeneous liquid.

Internal:Those which are used for internal purposes are called syrup. It is obtain by 65 % sugar solution.There are mainly 4 types of Sugar Solutions (Syrup) or meant for internal use manufactured by Emami ltd. These are as follows.
 Himani Lalima Syrup
 Himani Femi Plus Syrup
 Himani Memo Plus Syrup
 Himani Sardija Syrup

Himani Lalima Syrup: Himani Lalima is a blood & skin purifier.

Ingredients: Each 5ml contains
 Triphala (150mg) -> Improves blood circulation & provides nourishment.
 Anantamool (150mg) -> Purifies the blood naturally.
 Katuki (60mg) -> Purifies the blood naturally.
 Manjistha (75mg) -> Purifies the blood naturally.
 Haridra (150mg) -> For a fair complexion & glowing skin.
 Kesar (1mg), Vit E -> For a fair complexion & glowing skin.
 Guduchi (75mg) -> Clearers acne, pimples.
 Manjistha (75mg) -> Cleares acne, pimples.
 Nimba (75mg) -> Cures boils, blemishes, & rashes.
 Bhringharaj (75mg) -> Cures boils, blemishes, & rashes.
 Honey (0.1ml w/v) -> Rejuvates the skin.
 Chirata (60mg) ->
 Godhumankar Tel (Wheat Germ Oil) (5mg) ->
 Flavored Sugar Syrup base
 Preservatives (Methyl Paraben, Propyl Paraben, Sod. Benzoate) -> q.s
 Suagr
 Citric acid
 Tween 80
 Spearmint oil
 Menthol
 Camphor
 DM water

Process:
Ensure that all the ingd. equipment & accessories used in the mfg. are cleaned properly.
↓
Preparation of decoction of all herbs. All herbs are cleaned properly.
↓
Take the decoction of herbs to boiling tank & then add sugar to the tank( 700kg sugar for 1lt. decoction). Boil for 3-4 hrs.
↓
Then take the all matter to the mixing tank. Then add Methyl paraben, Propyl paraben, Sod. Benzoate, Flavor, Mint in interval of 25mins in each.
↓
After some time of mixing the final product is supplied to the storage tank.

Filling & Packing:
Empty container is taken
↓
Place the container on the stand & syrup is filled by machine.
↓
Cap is properly sealed
↓
Now the bottles are poured into the packets.
↓
Then these container are going through conveyer belt
↓
Then batch no. etc are printed

SOPs for Himani Lalima Syrup:
1. Objective -> To lay down a procedure for cleaning of decoction storage tank.
Scope -> This procedure is applicable to the decoction storage tank in syrup manufacturing area.
Procedure -> At the end of the day
i) Ensure that these is no decoction in the tank.
ii) Close the decoction transfer valve.
iii) Open the drain valve.
iv) Wash thoroughly with stream of plain water, till the drained water is clear.
v) Place a clean tag on the tank.

2. Objective -> To lay down a procedure for cleaning of sparkle filter in syrup manufacturing facility.
Scope -> This procedure is applicable to the sparkle filter in the syrup manufacturing facility.
Procedure ->
i) Close inlet & outlet valve of the sparkle filter.
ii) Drain out the hold up syrup.
iii) Discard the used filter papers.
iv) Take out the filter dishes.
v) Wash thoroughly with plain water.
vi) Rewash thoroughly with DM water.
vii) Visually check for any remaining debris & clean if any.
viii) Wipe dry the disk & inside of filter with clean, white cotton cloth, soaked in 70% IPA solution.
ix) Take new filter papers & fit them in the dishes.
x) Assemble the filter assembly.
xi) Affix ‘CLEANED’ tag on the equipment.

3. Objective -> to lay down a procedure for manufacturing of Himani Lalima Syrup.
Scope -> This procedure is applicable to syrup manufacturing.
Procedure ->
Step-1- Cleaned & chapped herbs are weighted as per batch card & taken jacked decoction pan. Req. qt. of water is added to it & boiled at 100°c - 110°c for about 3.5hrs (from starting to end) till TDS attains the value of 1.5%-2.5 %. It is kept for the 10-12 hrs. preferably for overnight. This ext. is collected & its vol. is measured to be 300lt. – 350lt. It is then filtered thoroughly filter cloth (100#) & stored in clean SS decoction storage vessel for the next step.
Step-2- Hot DM water is taken & to it formula qt. of Keshar is added & mixed by mixer to form paste.
Step-3- Aq. herbal ext. is transferred to the steam jacked sugar syrup pan. Now 700kg of sugar is added along with formula qt. of citric acid. This is boiled to 100°c-110°c under 2-3kg/cm² steam pressure with agitation. Then Sod. Benzoate & Methyl paraben & Methyl paraben is added to it. The syrup is prepared with final vol. 1lt.
Step-4- 1kg of wheat germ oil & 2kg of Tween 80 are taken in a SS container & stir properly for 30 mins.
Step-5- The sugar syrup is cooled by passing chilled water. Temperature is maintained at 45°c - 50°c. Now mix from step-4 is added. Then the mixture from step-2 is added. Menthol, Camphor, Spearmint Oil, & Honey is added. Mixing is continued for 30mins with slow stirring. Then the final syrup is passed through online sparkle filters. The finished pdt. Is transfer to the SS storage tank. Finally batch for the finished pdt. specification is cheeked & samples send to QC for analysis.



Femi Plus Syrup:
It is a liquid dosage form meant for internal use. It is an Ayurvedic female uterine tonic which helps to overcome cramps. Femi plus nourishes whole body & acts as female tonic. It rejuvenates female reproduction system thus acts as uterine tonic.
Ingredients: Each 5ml contains
 Lodhana -> 70mg
 Yastimadhu -> 62.5mg
 Ghritkumari -> 83mg
 Ashoka -> 70mg
 Satavari -> 60mg
 Apple juice -> 20mg
 Punarnava -> 70mg
 Jeevanti -> 83mg
 Nagkesar -> 60mg
 Svet Chandan -> 60mg
 Dasamool -> 60mg
 Rasna -> 60mg
 Triphala -> 40mg
 Devdaru -> 40mg
 Guduchi -> 20mg
 Hirabol -> 10mg
 Godhumonkar tel -> 5mg
Indication:
 Anti-cramps formula -> Dasamool, Devdaru & Rasna -> Useful in Cramps, pain & relieves stress.
 Diuretic properties -> Punarnava -> Relieves Micturation.
 Glowing Skin Action -> Vit E -> Improves Complexion.
 Haemateric properties -> Apple juice -> Provide Iron & energy.
 Flavored sugar syrup base.
 Preservatives -> Sod. Benzoate, Methyl Paraben, Propyl Paraben.





Process:Ensure that all the ingd., equipment & accessories used in the mfg. are cleaned properly.
↓
Preparation of decoction of all herbs. All herbs are cleaned properly.
↓
Take the decoction of herbs to boiling tank & then add sugar to the tank( 700kg sugar for 1lt. decoction). Boil for 3-4 hrs.
↓
Then take the all matter to the mixing tank. Then add Methyl paraben, Propyl paraben, Sod. Benzoate, Flavor, Mint in interval of 25mins in each.
↓
After some time of mixing the final product is supplied to the storage tank.

Filling & Packing:
Empty container is taken
↓
Place the container on the stand & syrup is filled by machine.
↓
Cap is properly sealed
↓
Now the bottles are poured into the packets.
↓
Then these container are going through conveyer belt
↓
Then batch no. etc are printed

SOPs for Himani Lalima Syrup:
1. Objective -> To lay down a procedure for cleaning of decoction storage tank.
Scope -> This procedure is applicable to the decoction storage tank in syrup manufacturing area.
Procedure -> At the end of the day
i) Ensure that these is no decoction in the tank.
ii) Close the decoction transfer valve.
iii) Open the drain valve.
iv) Wash thoroughly with stream of plain water, till the drained water is clear.
v) Place a clean tag on the tank.

2. Objective -> To lay down a procedure for cleaning of sparkle filter in syrup manufacturing facility.
Scope -> This procedure is applicable to the sparkle filter in the syrup manufacturing facility.
Procedure ->
i) Close inlet & outlet valve of the sparkle filter.
ii) Drain out the hold up syrup.
iii) Discard the used filter papers.
iv) Take out the filter dishes.
v) Wash thoroughly with plain water.
vi) Rewash thoroughly with DM water.
vii) Visually check for any remaining debris & clean if any.
viii) Wipe dry the disk & inside of filter with clean, white cotton cloth, soaked in 70% IPA solution.
ix) Take new filter papers & fit them in the dishes.
x) Assemble the filter assembly.
xi) Affix ‘CLEANED’ tag on the equipment.

3. Objective -> to lay down a procedure for manufacturing of Himani Lalima Syrup.
Scope -> This procedure is applicable to syrup manufacturing.
Procedure ->
Step-1- Cleaned & chapped herbs are weighted as per batch card & taken jacked decoction pan. Req. qt. of water is added to it & boiled at 100°c - 110°c for about 3.5hrs (from starting to end) till TDS attains the value of 1.5%-2.5 %. It is kept for the 10-12 hrs. preferably for overnight. This ext. is collected & its vol. is measured to be 300lt. – 350lt. It is then filtered thoroughly filter cloth (100#) & stored in clean SS decoction storage vessel for the next step.
Step-3- Aq. herbal ext. is transferred to the steam jacked sugar syrup pan. Now 700kg of sugar is added along with formula qt. of citric acid. This is boiled to 100°c-110°c under 2-3kg/cm² steam pressure with agitation. Then Sod. Benzoate & Methyl paraben & Methyl paraben is added to it. The syrup is prepared with final vol. 1lt.
Step-4- 1kg of wheat germ oil & 2kg of Tween 80 are taken in a SS container & stir properly for 30 mins.
Step-5- The sugar syrup is cooled by passing chilled water. Temperature is maintained at 45°c - 50°c. Now mix from step-4 is added. Then the mixture from step-2 is added. Menthol, Camphor, Spearmint Oil, & Honey is added. Mixing is continued for 30mins with slow stirring. Then the final syrup is passed through online sparkle filters. The finished pdt. Is transfer to the SS storage tank. Finally batch for the finished pdt. specification is cheeked & samples send to QC for analysis.



External
Those which are used for external purposes.

NAVARATNA OIL
It is a liquid dosage form meant for external use. It is a cool ayurvedic oil. It gives relief from stress & its symptoms like headache, tension, fatigue, & insomnia. It also reduces premature graying or hair fall.

Ingredients Brhami
 Amla
 Benamool
 Kesut
 Sailaj
 Kapur Kachari
 Ushir
 Lata Kasturi
 Gunja(Lalkunja)
 Aloe Vera
 L.L.P.

Raw material in sequel form
Preblend-1: Amla dry, Benamool, Brahmi, Kapoor kachari, Kesut, Lal kunch, Latakasturi, Shailaja, Til oil (Base).
Preblend-2: Tea tree oil, Pachauli oil, Yalng Yalng oil, Rosemary oil.
Preblend-3: Pudina ka oil, Pudina ka tel, Karpoor.
Preblend-4: COS oil tony red, COS oil qunizarine green, Light liquid paraffin.
Preblend-5: Til oil, Butyl hydroxyl toluene, Liquid paraffin.
Preblend-6: Perfume.

ProcessLine Clearance
↓
Herbal decoction in til oil
↓
Preparation of color solution in 10kg LLP
↓
Preparation of essential mixture, tea tree oil, Pachuli oil, Yalng Yalng oil, Pudina ka phool
↓
Final mixing- Til oil, LLP, BHT, herbal decoction, color solution, essential oil
↓
Material passed through the filter press

Filling & Packing:
Empty container is taken
↓
Place the container on the stand & oil is filled by machine.
↓
Cap is properly sealed
↓
Now the bottles are poured into the packets.
↓
Then these container are going through conveyer belt
↓
Then batch no. etc are printed

SOPs for Himani Navaratna Oil:
1. Objective: To lay down a procedure for manufacture of Navaratna Oil.
Scope: This procedure is applicable to the oil manufacture unit.
Procedure:
Stage-1: Weight quantity of cleaned herbs are cut into small pieces. 60 kgs of Til oil is taken in a suitable SS vessel & heated with constant stirring upto 80-90°c. Heating is stopped. The chapped herbs are next added to the oil. The total rate is left as such in a loosely covered condition for about 8-10hrs.
The liquid is filtered through 100# Nylon cloth into a cleaned SS vessel. Residual herbs are squeezed, so as to recover the soaked oil. The recovered oil is added to the filtrate. The vol is made upto 60kgs by adding required amount of refined til oil.
Stage-2: weighed quantity of color COS oil tony red, COS oil quinizarine green are wt. accurately & dissolve into a portion of LLP. The mixture is heated upto 80-85°c for effective dispersion of color. The color solution is stored in a fine nylon cloth. In case of any residual undispersed color particles, the same operation of dispersing in hot oil is repeated.
Stage-3: Formula quantity of Pudina Tel, Pudina ka Phool, Karpoor, Teatree oil, Pachauli oil, Rosemary oil, Yalng Yalnh oil taken mixed together in a SS vessel.
Stage-4: Formula quantity of Til oil, Rice bram oil, BHT are wt. & transfer to SS vessel provided with switable high speed Reni type stirrer. The stirrer is switched on. The stored oil based herbal mixture, color mix, & essential oil mix is mixed continue for about 1.5hr.
The entire mix is strained through a sparkler filter. The filtered oil stored in a SS vessel. The oil is next sent to the lab for analysis.

2. Objective: To lay down a procedure for cleaning of oil manufacture unit.
Scope: This procedure is applicable to the oil manufacture unit.
Procedure:
i) Drain out pdt. from system.
ii) Dismantle the strainer, press filter, sparkler filter from line.
iii) Manually scrolls the inner mall of the mixing vessel & intermediate storage tank, stirrer surface, strainer walls, plates & filter press plates with lint free cloth.
iv) Ensure zero residues of sediments.
v) Assemble the disintegrated parts of the strainer & filter press without cloth & put them on line.
vi) Splash the inner wall of the mixing vessel with about 40lt. of LLP run the LLP through the entire system of strainer & filter press.
vii) Drain out the entire rinsed LLP.
viii) Splash the inner wall of the intermediate storage tank with about 10lt of LLP & drain out the rinsed LLP.
ix) Repeat steps 5-7 in case smell of previous pdt.
x) Fix clean & fresh filter cloth.
xi) Place “CLEAN” tag on the unit.

3. Objective: To lay down a procedure for cleaning of oil filling machine.
Scope: This procedure is applicable to the oil filling machine.
Procedure:
i) Close the inlet valve to the filling buffer tank.
ii) Drain out pdt. from system.
iii) Take about 400lt of LLP is storage tank.
iv) Pass the LLP through all the interconnected vessel & the pipeline till the storage tank.
v) Ensure through mixing.
vi) Drain out LLP from system.
vii) Ensure that no LLP is in the loops & byepass.
viii) Dismantle parts of the sparkler filter including the filter plates.
ix) Wipe all parts of sparkle filter cloth in the filter press.
x) Close the vessels.
xi) Fix clean & fresh filter cloth in the filter press.
xii) Place “CLEAN” tag on the unit.




CHURNA or POWDER
Churna is fine dry powder or a drug or drugs. It is macerated without any liquid. Churna may be applied to the powder of a single drug or a mixture of two or more drugs which are powdered separately prior to their being mixed to homogeneity.
Powder are the solid dosage form of medicament which are meant for internal & external use.
Product:
 Good Morning Laxative Churna (Ayurvedic).
 Talc.




GOOD MORNING LAXATIVE CHURNA
It is a break through two action formulation Himani Ayurvedic Science Foundation. Its time tested herbs provide effective relief from Constipation. Special AYUR VM10 aids digestion, protects our system & rejuvate us to keep feeling fresh all day. Clinically proven to provide sure relief even in chronic cases.
Formulated by Pad. Vaidya Suresh Chaturvedi & Kaviraj Hari Shankar Sharma (former Dean, Gujrat Ayurvedic University, Jamnagar).

Ingredient:
 Mridurechani -> Laxative, Corrects the body system.
 Ajwayan -> Digestive, Carminative, Anti-flatulence, & useful in various Gastric problems.
 Haritaki -> Useful in Dysentery, Constipation.
 Indrayan -> Protects from cough & Cold, Gas.
 Sunthi -> Highly effective for curing Cough, Rheumatism & Constipation.
 Mint flower
 Spearmint oil
 Saindav lavan
 Eranda oil
 Surasor
 Pudina ka phool
 Propyl paraben
 Methyl paraben
 Sodium benzoate

Process:
Ensure that all the ingd. equipment & accessories used in the mfg. are cleaned properly.
↓
Preparation of powder of ingredients. All ingredient clean & grinded individually & sieve through 60# snafu is grinded & pass through 24#.
↓
Wt. accurately the required qty of the mint flower & spearmint oil & mix well in SS vessel.
↓
Required qty of Eranda oil, Surasar, Pudina ka Phool, Propyl paraben, Flower mixture, & Methyl paraben are mixed together manually in suitable SS container & keep aside.
↓
Req qty of herbal pdt, Saindava lavana, & Sod benzoate are mixed well & sieved the same through 14# sieve to ensure homogeneous mixing. The mixture should be used on that day.
↓
Add slowly the mixture obtained from step 4 into the main mixture & add well.
↓
Add flavor mixture into it & continue mixing for 40-45 mins. Then sieved the finished products 24# sieve & stored properly in closed container with proper level.

FILLING & SEALING:Empty container is taken
↓
Place the container on the stand & powder is filled by machine.
↓
Cap is properly sealed
↓
Then these container are going through conveyer belt
↓
Then batch no. etc are printed
Indication: For relief from chronic constipation & associated symptoms of flatulence, nausea, acidity, & indigestion. Eases bowel movement in painful conditions of piles & fissures.

SOPs for GOOD MORNING LAXATIVE CHURNA:1. Objective -> To lay down a procedure for line clearance of filling &packing operation.
Scope -> This SOP is applicable to filling & packing area.
Procedure ->
i) Check the area for cleanliness.
ii) Check for any residual material of previous batch like coded PM, non specified PM, diff. variant of finished goods, finished goods of other batch etc.
iii) Check the humidity & temperature.
iv) Check coding, fill vol./wt.
v) If adjustment M/C adjustment are done, discard the trial packs.
vi) Place a tag bearing the pdt name, batch no.
vii) If everything is as per norms allow packing/ filling operation.
viii) Don’t allow persons suffering from infections disease in the filling packing area.
ix) Record the line cleaned procedure in specified format & get it countersigned by the production supervisor.

2. Objective -> To lay down a procedure for manufacturing of Good Morning Laxative Churna (GMLC).
Scope -> This procedure is applicable to GMLC dept.
Procedure ->
Materials Used:
 Sonamukti
 Ajwayana
 Indrayan
 Haritaki
 Sunthi
 Saindhava lavana
 Eranda oil
 Menthol
 Methyl paraben
 Sodium Benzoate
 Flavour(mint)
 Spearmint oil
Step-1: Formula qt. of grinded herbs are sieved through 60 mesh & mixed manually. Then herbs are dried to a moisture content to 3-4%. Formula qt. of Saindhava lavana is grinded & sieved through 60 mesh & 14 mesh successively.
Step-2: Dried herbs are taken into a ribbon blender. Formula qt. of menthol, spearmint oil, eranda oil, sod. Benzoate, methyl paraben, propyl paraben, flavor & saindhava lavana are added to the blender. Mixed for 30 min.
Step-3: The bulk is unloaded & sieved through 14 mesh & stored in closed vessels. The bulk is sent for QC checking & approval.

3. Objective -> To lay down a procedure for maintaining ideal condition of the HCD primary packing area.
Scope -> This SOP is applicable to HCD primary packing area.
Procedure -> Following conditions are to be maintained.

Product Temperature(°c) Humidity(%)
Syrup 20-40 NMT 60
Chyawanprash 20-40 NMT 85
Capsule 22-27 NMT 50
Tea 20-30 NMT 50
GMLC 20-30 NMT 50
BMO 20-40 NMT 60

4. Objective: To lay down a procedure for cleaning of GMLC pouch filling machine.
Scope: This SOP is applicable to GMLC pouch filling machine in the packing dept.
Procedure: a) Regular
i) Thoroughly clean the hopper & other parts with air jet.
ii) Run the machine without any materials to check for operational defects.
iii) If there is no problem the machine is ready for operation.
iv) Check for wt., vol., coding before start.
b) Start & end of season
i) Dismantle the machine parts & keep them on a plastic tray.
ii) Clean the machine body with dry cloth.
iii) Mop the machine parts with fibre free duster soaked in 70 % IPA solution.
iv) Reflex the parts.
v) Run the machine without any materials to check for operational defect.
vi) If there is no problem the machine is ready for operation .
vii) Check for wt., vol., & coding before start.

5. Objective: To lay down a procedure for cleaning & sanitation of manufacturing area.
Scope: This SOP is applicable to GMLC dept.
Procedure:
i) Sweeper must wear Ear marked dress, Gloves, Caps & Musk.
ii) Sweep the floor with duster or vacuum cleaned
iii) Clean floor & walls with liq. soap solution dil in water.
iv) Repeat process 3, twice if req.
v) Fans may be switched on for quick drying.

6. Objective: To lay down a procedure for operation of fluid bed dryer.
Scope: This SOP is applicable to the manufacturing dept.
Procedure:
i) Clean the inside of fluid bed dryer with IPA solution.
ii) Remove all traces of IPA by blowing hot air.
iii) Fill the powdered material to be dried in the machine after proper weighment.
iv) Set the hot air inlet & check the temperature.
v) Start the machine.
vi) Stop the machine time to time.
vii) Take out some sample from the test portal each time & check the moisture content.
viii) Continue the drying process till the desired moisture level is attained.
ix) Remove the dried materials from the drier & store properly for
Further process.

7. Objective: To lay down a procedure to fumigate the packing area.
Scope: This SOP is applicable to GMLC packing dept.
Procedure:
i) Raw material, finished goods, intermediates or in-process goods, are kept outside the area.
ii) Doors needed to be closed.
iii) AC & AHU to be switched off before starting fumigation.
iv) “Area Under Fumigation, Don’t Enter” status level should be displayed
v) Food grade glutarldehyde to be spread in its pure form.
vi) The room is kept closed for 12 hrs.
vii) The whole area is cleaned with water the next day.
viii) The growth of the microorganism is checked by the micro labs.
ix) Fumigation to be done at regular intervals & records to be preserved.




CAPSULE
Mothes & Dublanc, two Franchmen, are generally credited with the invention of the gelatin capsule. Their patents, granted in March & December of 1834, covered a method for producing single piece, olive shaped, gelatin capsules, which were closed after filling by a drop of concentrated warm gelatin solution. The two piece telescoping capsule, invented by James Murdock in 1865.

Product
 Femi plus capsule

FEMI PLUS CAPSULE
An ayurvedic female uterine capsule which helps to overcome cramps. Femi plus nourishes whole body & acts as female capsule. It rejuvates female reproduction system thus acts as uterine capsule.

Ingredients  Lodhara
 Hirabol
 Yastimadhu
 Ashoka
 Satavari
 Nagkeshara
 Sweet Chandana
 Devdaru
 Guduchi
 Rasna
 Punarnava
 Dasamool
 Mandura Bhasma
 Mukta Sukti Bhasma
 Calcium Phosphate Dibasic
 Sodium Silicate


Process
Dried powder of all ingredients are collected from the market
↓
Mix them well in the mixer
↓
Put the in the hopper of the capsule filling machine
↓
Powder are filled into the capsule
↓
Then it placed into a vacuum pressure for compaction
↓
Then placed the capsule in the manual shorting machine
↓
Then placed it in mechanical shorting machine from where the dust are cleaned
↓
Then it undergoes through polisher

Packaging
Now the finished capsules are goes to the packaging table
↓
Now 30 capsule are arrange to pack in a bottle
↓
Now this bottles are stored & waiting for dispatch
↓
Lastly batch no. etc. are printed

Indication:
 Anti-cramps formula -> Dasamool, Devdaru & Rasna -> Useful in Cramps, pain & relieves stress.
 Diuretic properties -> Punarnava -> Relieves Micturation.
 Glowing Skin Action -> Vit E -> Improves Complexion.
 Haemateric properties -> Apple juice -> Provide Iron & energy.
 Flavored sugar syrup base.
 Preservatives -> Sod. Benzoate, Methyl Paraben, Propyl Paraben.

SOPs for Femi plus capsule
1. Objective -> To lay down a procedure for maintaining ideal condition of the HCD primary packing area.
Scope -> This SOP is applicable to HCD primary packing area.
Procedure -> Following conditions are to be maintained.

Product Temperature(°c) Humidity(%)
Syrup 20-40 NMT 60
Chyawanprash 20-40 NMT 85
Capsule 22-27 NMT 50
Tea 20-30 NMT 50
GMLC 20-30 NMT 50
BMO 20-40 NMT 60

2. Objective: To lay down a procedure to fumigate the packing area.
Scope: This SOP is applicable to Femi plus capsule packing dept.
Procedure:
i) Raw material, finished goods, intermediates or in-process goods, are kept outside the area.
ii) Doors needed to be closed.
iii) AC & AHU to be switched off before starting fumigation.
iv) “Area Under Fumigation, Don’t Enter” status level should be displayed
v) Food grade glutarldehyde to be spread in its pure form.
vi) The room is kept closed for 12 hrs.
vii) The whole area is cleaned with water the next day.
viii) The growth of the microorganism is checked by the micro labs.
ix) Fumigation to be done at regular intervals & records to be preserved.

3. Objective: To lay down a procedure for cleaning & sanitation of manufacturing area.
Scope: This SOP is applicable to Femi plus capsule dept.
Procedure:
i) Sweeper must wear Ear marked dress, Gloves, Caps & Musk.
ii) Sweep the floor with duster or vacuum cleaned
iii) Clean floor & walls with liq. soap solution dil in water.
iv) Repeat process 3, twice if req.
v) Fans may be switched on for quick drying.
vi) Swab with fiber free duster dipped in 2% savlon solution.

4. Objective: To lay down a procedure for sanitation in the capsule packing area.
Scope: This SOP is applicable to capsule packing section.
Procedure:
i) Floor, Machine, Walls has to be cleaned on a daily basis ensure that doors, windows, electrical panels are dust free.
ii) Clean the machine with IPA solution & floor with liq. detergent before & after production.
iii) All utensils to be cleaned with IPA solution & kept dry.
iv) Room condition to be maintained as specification.
v) Persons working in the area should have aprons, caps, gloves, masks, rubber slipper/ shoe cover.
vi) Every one should wash their hands with 70% IPA solution to avoid contamination before entering the capsule packing area.
vii) Perform Microbiological test at routine intervals.
viii) Clean machine with 70% IPA solution everyday before start of packing operation.

5. Objective -> To lay down a procedure for line clearance of filling &packing operation.
Scope -> This SOP is applicable to filling & packing area.
Procedure ->
i) Check the area for cleanliness.
ii) Check for any residual material of previous batch like coded PM, non specified PM, diff. variant of finished goods, finished goods of other batch etc.
iii) Check the humidity & temperature.
iv) Check coding, fill vol./wt.
v) If adjustment M/C adjustment are done, discard the trial packs.
vi) Place a tag bearing the pdt name, batch no.
vii) If everything is as per norms allow packing/ filling operation.
viii) Don’t allow persons suffering from infections disease in the filling packing area.
ix) Record the line cleaned procedure in specified format & get it countersigned by the production supervisor.

6. Objective: To lay down a procedure for packing material.
Scope: This SOP is applicable to central source.
Procedure:
i) Persons dispensing PM must wear clean ear marked drees & cap.
ii) Area of working in the dispensing zone must be free from unwanted PM .
iii) Issue of PM is done against requisition slip raised by the production dept.
iv) Approval tags must be checked before issue of the materials.
v) Visual identification before dispensing to be done especially for the printed PM as extra precautionary measure.
vi) After completion of the issuance procedure the requisition slip must be countersigned by the stores supervisor as well as the production supervisor.
vii) The requisition slip is finally stored for reconciliation.

7. Objective: To lay down a procedure for dispensing of herbs.
Scope: This SOP is applicable to herbs store.
Procedure:
i) Keep the material ready as per requisition received from the manufacturing dept.
ii) Check the balance for its proper functioning.
iii) Check the cleanliness of the area before dispensing the materials.
iv) Check the cleanliness of the dispensing utensils before dispensing the materials.
v) Recheck the levels of the materials to be dispensed.
vi) Dispense the materials with a clean spoon in a plastic SS can.
vii) Check the wt. of the bags of individual items after dispensing for reconciliation.
viii) Clean the dispensing utensils & the area before next dispensing operation.


8. Objective: To lay down a procedure for dispensing of raw materials.
Scope: This SOP is applicable to central stores.
Procedure:
i) Persons dispensing RM must wear clean ear marked dress, cap, gloves, & washable slipper.
ii) Dispensing zone must be clean & free from dust.
iii) Check the cleanliness of dispensing equipments before dispensing.
iv) Dispensing must be done with the help of a calibrated balance.
v) Area of working in the dispensing zone, dispensing equipment must be free from unwanted RM.
vi) Issue of RM is done against BPA given by the manufacturing dept. which is already given by QA dept.
vii) Approved tags must be checked before issue of the materials.
viii) Visual identification before dispensing is to be done.
ix) Net quantity dispensed is verified & recorded by stores & manufacturer supervisor.
x) The entire process of issuance of RM must be thoroughly monitored by supervisor.
xi) The loose plastic bags or containers must be properly closed & transferred to the production area with proper identification.
xii) After completion of the issuance procedure, BPR page no.-1 must be countersigned by the stores supervisor as well as the production supervisor.
xiii) The print out obtained from SAP is finally attached with the BPR.





CREAM
Product
 Himani Fast Relief
 Boroplus Antiseptic Cream

BORO PLUS
It is an ointment with ayurvedic base, it can be cure nicks, cuts, burns, nappy rash etc. protects the skin from minor disease & harsh weather. It is widely used for the treatment of chapped, cracked & dry skin during extreme winter.
The cream penetrates the skin gently. It has a rich Aloe vera content along with neem, cures minor burns, other ingredients like usir keep the skin cool & relaxed.

Ingredients Boric acid
 Zinc oxide
 Talc
 Hard paraffin
 Sasol wax
 L.L.P.
 Cito
 Lanoline
 S.L.S.
 Hydral 20
 Tincture of herbs
 Alcoholic ext. of herbs.
 Perfume.

Boro plus production in flow chart
Stage 1
Aq. mixing using formula qty. of herb ext.

Stage 2
Mixing of preblend3

Stage 3
Powdered chemical ingredients as per formula are sieved together through 60 # sieve, mixed with mineral oil.
↘
Mixed
Stage 4
Preblend4 material. Consisting of waxes & mineral oil are melted at about 90°c.
↓
Filtered
↓
Now all together this 4 Stage 1, 2, 3, 4
↓
Batch mixing kettle
↓
Start homogenizing after addition of 1 & 2.
↓
Start stirring after addition of 3 continue homogenizing till 60-65°c.
↓
Stop homogenizing at 65°c, continue mixing, start water circulation for cooling.
↓
Start chilled water circulation after 5n min of perfume adition.
↓
Reworked product if any & add preblend5 ( perfume)
↓
Milled through a colloid mill at about 37°c & store in SS bulk storage tank.↓
↓
Filling Packing
↓
Finished goods
↓
Dispatch Store


SOPs for Himani Fast Relief
1. Objective: To lay down a procedure for cleaning of cream filling machine.
Scope: This SOP is applicable to the tube filling machine in the packing dept. during charge over the product.
Procedure:
i) Take out excess cream from the Ratopump Hopper & pipeline. Run the machine to take out cream from the primary hopper. Ensure that there is no cream in the system.
ii) Store the cream separately in a HDPE vat.
iii) Return the cream to the manufacturing dept. for reprocessing.
iv) Dismantle the hopper, nozzle valve, piston, cassette of the filling machine & keep them in a clean tray.
v) Clean the parts thoroughly with fiber free dry cloth.
vi) Finally wipe with fiber free duster soaked in IPA solution.
vii) Put fresh cream hopper & rinse the pump & pipeline with the desired cream till the new variant is totally identified in output.
viii) Discard the rinsed cream.
ix) Fix all the parts of the filling machine.
x) Rinse with desired cream till new variety is totally identified in the output.
xi) Rinsed cream to be discarded.
xii) Placed clean tag on the machine.

2. Objective: To lay down a procedure for effective cleaning of cream manufacturing facility.
Scope: This SOP is applicable to the Ayurvedic cream manufacturing facility.
1.0 Health, Safety, & Environment:
1.1 Use hand gloves before cleaning.
1.2 Use head caps, marks before entering the production area.
2.0 Procedure:
2.1 Product charge over
2.1.1 Ensure the complete removal of product from manufacturing plant.
2.1.2 Remove the “USE FOR” tag & fix “TO BE CLEANED” level on the manufacturing vessel.
2.1.3 Ensure that the bottom drain valve & manhole lid is closed of melting vessel.
2.1.4 Set the temp of melting vessel at 90°c for 30 mins.
2.1.5 Open the bottom valve & drain out the valve.
2.1.6 Collect purified water in the melting vessel.
2.1.7 Set the temp of water at 90°c.
2.1.8 After achieving desired temp, run the agitator for around 20 mins & next transfer water to the mixing vessel under vacuum. Maintain a temp of around 90°c in the mixing vessel.
2.1.9 Connect one end of CIP pump to the outlet of storage mixing vessel.
2.1.10 Connect other end of P pump to the outlet of storage tank. Open the valve between mixing vessel & colloid mill.
2.1.11 Start the CIP pump for circulation of hot water from mixing vessel through transfer pump & storage tank. Start the agitator of the mixing vessel & maintain the temp. of purified water at about 90°c.
2.1.12 After circulation for about 30 mins free the output of storage tank & drain out water.
2.1.13 Take sufficient amount of water in the mixing vessel.
2.1.14 Flash required amount of IPA in the melting vessel & keep it close for one hr. then drain out.
2.1.15 Keep the melting vessel open & maintain the temp at about 60°c for effective drying.
2.1.16 Flash require amount of IPA in manufacture tank & keep it close for 1hr. then dried out. Through colloid mill transfer pump & storage tank.
2.1.17 Keep the manufacturing tank open & maintain the temp at about 60°c for effective drying.
2.1.18 Dismantle the transfer lines strainer & clean the same with hot purified water, & then rinse with IPA.
2.2 Variant change over
2.2.1 Ensure the complete removal of previous product.
2.2.2 Remove the “USE FOR” tag & attach the “TO BE CLEANED” level to the manufacturing plant.
2.2.3 Set the temp of mixing vessel at 90°c. Switch on the agitator & drain out residue previous product through the bottom valve.
2.2.4 Close the mixing point of vessel.
2.2.5 Take required amount of L.L.P. in the mixing vessel through spray nozzle.
2.2.6 Maintain the temp of L.L.P. at 90°c.
2.2.7 Switch on the agitator. Continue for about 45mins. Next drain out the hot L.L.P. through flash nozzle.
2.2.8 Dismantle the transfer lines, strainer & clean the same with in hot water & then rinse with IPA.
2.2.9 Repeat process 2.2.3-2.2.8 in case of there is a residue of previous product.




HIMANI FAST RELIFE
It is an ointment with ayurvedic base, provides instant relief against masculer, joint, arthritic & shoulder pain.

Ingredients Wintergreen oil
 Menthol
 Eucalyptus oil
 Camphor
 Turpentine oil
 Clove oil
 Thymol
 L.L.P.
 Hard Paraffin
 Coloring agent
 Base

Indication
Powerful therapy for symptomatic relief from arthritic muscular pain, backache, joint pains, sprains, sciatica, inflammation.

Boro plus Production in Flowchart
Stage 1Formula qty. of blend 1 (containing essential oil, herbal actives, anti-oxidants) are wt. mixed together & left as such in closed container until a homogeneous solution is obtained.
↓ ↖
Filtered Preblend 2 (containing color solution)


Stage 2
Formula qty. of Preblend 3 (consisting of waxes & mineral oils are wt. together & heated upto 85-90°c with constant stirring.
↘
Filter
Stage 3Both the products from stage 1 & stage 2 are then goes to the Batch Mixing Kettle
↓
Start mixing cum side scrapping
↓
Continue mixing & scrapping
↓
Continue high speed mixing for 30 mins after transfer of Preblend 1 & 2.
↓
Start water circulation for cooling continue mixing at lower speed till temperature reaches 40-45°c.
↓
Reworked product if any will add to it (add at 55-60°c)
↖
Release the batch to properly closed SS tank.
↓
Filling Packing
↓
Finished goods
↓
Dispatch Store

Procedure

Oil Phase
 L.L.P
 Hard Paraffin
 MC Wax
 Ozokenite Wax
 H.L.P.
↓
Transfer to mixing vessel
↓
Add essential oils
 Methyl Salicylate
 Menthol
 Wintergreen oil
 Eucalyptus oil
 Camphor
 Turpentine oil
 Clove oil
 Thymol
↓
Add color
↓
Run water for cooling
↓
Then transfer to storage tank

SOPs for Himani Fast Relief
1. Objective: To lay down a procedure for cleaning of cream filling machine.
Scope: This SOP is applicable to the tube filling machine in the packing dept. during charge over the product.
Procedure:
i) Take out excess cream from the Ratopump Hopper & pipeline. Run the machine to take out cream from the primary hopper. Ensure that there is no cream in the system.
ii) Store the cream separately in a HDPE vat.
iii) Return the cream to the manufacturing dept. for reprocessing.
iv) Dismantle the hopper, nozzle valve, piston, cassette of the filling machine & keep them in a clean tray.
v) Clean the parts thoroughly with fiber free dry cloth.
vi) Finally wipe with fiber free duster soaked in IPA solution.
vii) Put fresh cream hopper & rinse the pump & pipeline with the desired cream till the new variant is totally identified in output.
viii) Discard the rinsed cream.
ix) Fix all the parts of the filling machine.
x) Rinse with desired cream till new variety is totally identified in the output.
xi) Rinsed cream to be discarded.
xii) Placed clean tag on the machine.

2. Objective: To lay down a procedure for effective cleaning of cream manufacturing facility.
Scope: This SOP is applicable to the Ayurvedic cream manufacturing facility.
1.0 Health, Safety, & Environment:
1.1 Use hand gloves before cleaning.
1.2 Use head caps, marks before entering the production area.
2.0 Procedure:
2.1 Product charge over
2.1.1 Ensure the complete removal of product from manufacturing plant.
2.1.2 Remove the “USE FOR” tag & fix “TO BE CLEANED” level on the manufacturing vessel.
2.1.3 Ensure that the bottom drain valve & manhole lid is closed of melting vessel.
2.1.4 Set the temp of melting vessel at 90°c for 30 mins.
2.1.5 Open the bottom valve & drain out the valve.
2.1.6 Collect purified water in the melting vessel.
2.1.7 Set the temp of water at 90°c.
2.1.8 After achieving desired temp, run the agitator for around 20 mins & next transfer water to the mixing vessel under vacuum. Maintain a temp of around 90°c in the mixing vessel.
2.1.9 Connect one end of CIP pump to the outlet of storage mixing vessel.
2.1.10 Connect other end of P pump to the outlet of storage tank. Open the valve between mixing vessel & colloid mill.
2.1.11 Start the CIP pump for circulation of hot water from mixing vessel through transfer pump & storage tank. Start the agitator of the mixing vessel & maintain the temp. of purified water at about 90°c.
2.1.12 After circulation for about 30 mins free the output of storage tank & drain out water.
2.1.13 Take sufficient amount of water in the mixing vessel.
2.1.14 Flash required amount of IPA in the melting vessel & keep it close for one hr. then drain out.
2.1.15 Keep the melting vessel open & maintain the temp at about 60°c for effective drying.
2.1.16 Flash require amount of IPA in manufacture tank & keep it close for 1hr. then dried out. Through colloid mill transfer pump & storage tank.
2.1.17 Keep the manufacturing tank open & maintain the temp at about 60°c for effective drying.
2.1.18 Dismantle the transfer lines strainer & clean the same with hot purified water, & then rinse with IPA.
2.2 Variant change over
2.2.1 Ensure the complete removal of previous product.
2.2.2 Remove the “USE FOR” tag & attach the “TO BE CLEANED” level to the manufacturing plant.
2.2.3 Set the temp of mixing vessel at 90°c. Switch on the agitator & drain out residue previous product through the bottom valve.
2.2.4 Close the mixing point of vessel.
2.2.5 Take required amount of L.L.P. in the mixing vessel through spray nozzle.
2.2.6 Maintain the temp of L.L.P. at 90°c.
2.2.7 Switch on the agitator. Continue for about 45mins. Next drain out the hot L.L.P. through flash nozzle.
2.2.8 Dismantle the transfer lines, strainer & clean the same with in hot water & then rinse with IPA.
2.2.9 Repeat process 2.2.3-2.2.8 in case of there is a residue of previous product.





CONCLUSIONIts my privilege & a lifetime achievement of mine to work with ‘Emami group’. Here I saw production of many successful formulations of Emami. The employees of Emami are just so friendly & helpful. They give every possible help to me. I am really very proud to be in Emami.
Lastly I want to give thanks to all the employees of the Emami Ltd. who guided me for completion of my project.