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School of Pharmacy & Technology Management, NMIMS

SUMMER TRAINING

Presented by:

Janu Pandya

Roll No - 03MBA Pharmtech 4th year

NMIMS, Mumbai

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CO NTENTS:

� INTR ODU C TI O N

� PR ODU C TS

� PR ODU C TI O N PLANTS

� INJE C

TIBLE PLANT � INFUSI O N PLANT

� API PLANT

� QC DEPARTMENT

� QA DEPARTMENT � UTILITY


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C LARIS at a glance«««.

� Founded in 1999, was the secondentrepreneurial venture of Mr. Sushil Handa.

� Current CEO and MD, Mr. Arjun Handa.

� Claris Lifesciences is an international pharmaceutical company, in the business of

manufacturing and marketing sterile

parenteral preparations, life saving

medicines and hospital products, focusingon delivery systems, for treatment of critical

illnesses and diseases.


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PR ODU C TS«.� With emphasis on Research, Technology and Quality, Claris

offers a range of unique products and delivery systems in bottles,vials, ampoules, pre-filled syringes, non-PVC/PVC bags and oraldosage forms.

� The company's strength lies in its know-how and expertise inmanufacturing and marketing injectable products.

� ANAESTHESIA:

� NUTRITION

� PLASMA VOLUME EXPANDERS

� BLOOD PRODUCTS

� ONCOLOGY

� INFUSION THERAPY

� SELECT INJECTIBLES

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� IT¶S CO MPETITIVE E DGE...???

� 1st to introduce several products in India

� No single Indian company having similar product

focus

� Few International competitors

� Extensive S&D network

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PR ODU C TI O N PLANTS

� Located at Bawla, spread over 78 acres of land near Ahmedabad, having total 5 production units, namedµClarion¶.

� Clarion 1- Injectibles� Clarion 2- Infusion Plant

� Clarion 3- API production unit

� Clarion 4- NPVC bags

� Clarion 5- in pipeline


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C larion 1: INJE C TIBLES PLANT

� USFDA approved plant of clarion. The products producedhere are- 1% profol,RL solution for injections, fluconazole

injection, furosemide injection, atropine.

� This plant utilizes the latest manufacturing methods of FFS

technology. It follows various sops for production of lifesaving drugs. It includes various departments from stores,

production, QA, QC, IPQA, packing and dispatch.

� There are four lines:

1. Non PVC Bag lines

2. Aqueous line

3. PFE line (Parenteral Fat Emulsion)

4. SVP line (small volume parenteral)School of Pharmacy & Technology Management, NMIMS

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1. Plant Layout

2. Dispensing Area

3. Mixing and Holding Area

4. Filling Area

5. Sterilization Area

6. Packing Area

7. GQA8. FGQA

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PLANT LAY O UT

� Linear flow of manufacturing in the centre of thelocation and covered by four corridors.

� Support function at the sides of the location i.e. Stores,

QA, QC.

� Four point entries from all the sides i.e. Change

Rooms, Visitor Entry, Loading point, unloading point.


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DISPENSING AREA

� Material unloaded is verified by store person and if the materialis not OK then it is sent to the rejected area. If the material is OK

then it is intimated to the QC department, which undergoes the

process of sampling, under testing, released after approval.

� As per plan, production department issues the RM, PPM, SPMas per the BMR.

� Material is dispensed in presence of Production Chemist and

IPQA person under LAF with vertical flow, which comes from

HEPA (0.3 micron) and also created the positive pressure to

avoid surrounding air to get in the LAF, starts before 30 min of

dispensing.

� Once the material is dispensed, then it is transferred to the

mixing area through the hatch.


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MIXING AN D H O LDING AREA

� Once the material dispensed is mixed in the mixingtank with WFI.

� For generation of DRO and WFI there is

independent water system plant which is also called

as multicolumn distillation plant, which has

capacity to generate the WFI up to 2200lt/hr and the

storage capacity is 5000 litres. Similarly the

capacity of DRO generation is 2500 litre/hr and the

storage capacity is 3000 litres.

� After the mixing bulk sampling is done and then it

is transferred to Holding vessel through the 1.2

micron and 0.2 micron filtersSchool of Pharmacy & Technology Management, NMIMS

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FILLING AREA

Roll of Non PVC is set according to die for differentcapacity, i.e. 200 ml, 500 ml, 1000 ml.

Printing is done on the roll. Wielding is done. Filling is

done.

Spike pod and EMP are inserted in the bag.

The capacity of bag filling is 15,000 bags per day.

After filling the zero sampling test is done by the QC.


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STERILISATI O N AREA

� Once the bags are filled then they aretransferred to trolleys and are taken for

sterilization.

� There are total 3 Sterilizers.

� SBM, Germany(PFE-line)- One rotary

sterilizer, Water type, 105 degree and 65 Mts.

� Shinva, China (other than PFE line)- Two

steam Air type, PSG is used, 121 degree and17 Mts.


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PACK ING LINE

� There are four lines of packing.

� Vials are carried out to VIT both where damage vials, particle , fibre if seen in the vials are rejected.

� In the packing area female workers who are authorized andat a stretch they work in packing line for 30 minutes at theVIT booth. After a break of 1.5 hrs, they further do their work at the VIT booth. After the VIT, the labeling is doneon the vials.

� Vials, bottles ampoules are packed in the mother box andthen the C-boxes.

� Weighing and strapping is done and then finally palleting isdone.


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� GQA

� C- boxes are placed in GQA( Goods quarantine area)where they undergo the sterility test by QC for 15 daysand after the approval by QA they are transferred toFGQA( Finished Goods Quarantine Area)

� FGQA

� Once the product is approved, and then they are readyfor the dispatch as per requirement in the market.


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C larion 2: INFUSI O N PLANT

1. Plant layout

2. Dispensing area

3. Mixing and holding area

4. Filling area

5. Sterilization area

6. Packing area

7. GQA

8. FGQA

� Common solutions, multiple electrolytes, diuretics,

dehydrating solutions, IV infusion bottles, IV injections

are produces in this plant.

� This process is followed as per the SOP of life saving

drugs. School of Pharmacy & Technology Management, NMIMS

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PLANT LAY O UT

� Linear flow of manufacturing in the centre of the locationand covered by four corridors.

� Support function at the sides of the location i.e. stores,QA/QC.

� Four entries from all the sides i.e. change rooms , visitor

entry, loading point and unloading point.� There are 6 lines:

1. Line 1 ± Single mould

2. Line 2 ± Double mould

3. Line 3 ±single mould4. Line 4 ± single mould

5. Line 5 ± double mould

6. Line 6- bag line


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DISPENSING AREA

� Material unloaded is verified by store person and if thematerial is not OK then it is sent to the rejected area.

� If the material is OK then it is intimated to QCdepartment, which undergoes the process of sampling,under testing and release after approval.

� As per the plan, the production department issue the RM,PM, as per BMR. Material is dispensed in presence of Production Chemist and IPQA person under LAF withvertical flow, which comes from HEPA (0.3 micron) andalso created the positive pressure to avoid surroundingair to get in the LAF, starts before 30 min of dispensing.

� Once the material is dispensed, then it is transferred tothe mixing area through the hatch.


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MIXING AN D H O LDING

� Once the material dispensed is then mixed in themixing tank with WFI.

� For generations of ROEDI and WFI, there is aindependent water system plant which is also

called as multicolumn distillation plant, whichhas capacity to generate the WFI up to 6000litres/ hr and store capacity is 20000 litres.Similarly the capacity of ROEDI generation is9000ltr/hr and the storage capacity is 20000 lit

� After the mixing , bulk sampling is done andthen it is transferred to holding tank through the5 micron filter pad, 1.2 micron and 0.2 micron.


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FILLING AREA

� Rommelog Machine of Germany based on the FFStechnology.

� The plastic granules are processed in the machine

wherein they get heated and pass through the

moulds and plastic bottles are formed.

� After the formation of plastic bottles there is filling

and then sealing.

� 7 Bottles come out in every 7.2 seconds.� After filling zero sampling is done by QC.


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PACK ING LINE

� There are 12 belts of packing for bottle line and 1 belt for bagline. Firstly leak testing is done. Bottles are carried to VIT

booth where particle , fibre if seen is rejected.

� In the packing area , female workers are working who areauthorized and at a stretch they work in packing line for 30

minutes at VIT booth. After a break of 1.5 hrs they further dotheir work at VIT booth.

� After the VIT, insertion of cap on the bottles is done.

� Then the labeling is done on the bottles. Pouching is done bythe flow wrapping machine.

� Bottles are packed in mother box by auto cartoning machineand C- box filling is done.

� Strapping is done.

� Finally the C- boxes are transferred to GQA

area.


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API PLANT

� Supplies API to all other plants.

� It produces hydroxyethyl starch and iron sucrose.

� It also produces WFI for store area , production , QA

and QC area. This plant supplies API required to all the plants. The main aim is to supply the best API for

production of medicines to increase the quality of

production.Hydroxyethyl starch, iron sucrose are

mainly produced in this plant. Moreover it also storesWFI for stores, QA and QC departments.


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QC DEPARTMENT

� QC department in all the plants various tests for checkingthe quality of the product from raw material testing ti

finished product. Various tests performed are

microbiological, physical and environmental.

� QUALITY ANALYSIS TESTS

� Autoclave for media discard

� BET- Bacterial endotoxin test

� Bioburden

� Clean room maintenance� Media preparation

� Microbiological analysis of compressed air

� Sterility testing

� Sterility of microbiological room entry/exit behavior School of Pharmacy & Technology Management, NMIMS

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QA DEPARTMENT

� Maintains the documents, does validation and looks

upon the work done by QC department.


� C aliberation

� Qualification

� ValidationPR OC ESS

VALI D ATI O N

� Environmantal Validation� Physical validation

� ValidationMI C R O VALI D ATI O N

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UTILITY

� Utility provides the basic requirements to the pharmaceutical company.

� Functions:

� Operation

� Break down maintenance

� Preventive maintenance

� Training and implementation

� Engineering stores

� Safety


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THAN K Y O U THAN K Y O U


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claris (2)