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.
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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.
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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.
