Procedure for entry and exit in Manufacturing Area

Procedure for entry and exit in Manufacturing Area

Procedure

Entry in Manufacturing Area-I

Open the door of air lock of manufacturing area-I and enter into the air lock.

Take an apron from SS cabinet and wear it.

Ensure the nose mask & cap is wore.

Wear the hand gloves.

Disinfect hands with 70% IPA.

Open the door and enter in to manufacturing area-I.

Exit from Manufacturing Area-I.

Open the door and enter into the air lock.

Remove the apron and keep it in the “Used linen Bin”.

Open the door and exit from manufacturing area-I.

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Procedure for entry & exit in sterile area sterile area.

Procedure for entry & exit   in sterile area sterile area.

Precautions :

Among all the persons duly entered in sterile area, only

those whose names are laid down in the list are applicable for

this procedure.  Others are not permitted strictly.

Ensure about the overall cleanliness of change room.

Aware about the personal hygiene during all activities.

Do not touch any surfaces with hands.  Try to use elbow for pushing

the door during entry.

Do not make rapid movement.

Enter in to next change room only when the door of first one is closed.

Gowning procedure is strictly followed as per laid down sequence.

Try to Keep yourself inside the sterile area for half session of the work.

Avoid talking, if required use gestures preferably.

Entry Procedure :

Airlock – I

Open the door of Airlock – I and enter in to the Airlock – I

Take out your footwear meant for manufacturing premises and keep them on

the rack provided therein .

Remove the factory garments and keep it in the cupboard.

Push the doors slowly and take entry in air lock –II.

Airlock – II

Disinfect your hands with filtered 70% IPA.

Pick up a set of sterilized garments from cupboard having

Do the gowning strictly as per laid down sequence as mentioned below. While gowning the sterile dress should not touch to the floor.

Headgear      

Boiler suit (single piece)

Booties

footwear

Look at mirror for tidiness and neatness and then only enter in third air lock

by opening the door gently with the help of elbow. 

Airlock – III

In third air lock, disinfect your hands with filtered 70% IPA.

Pick up a set of sterile hand gloves and wear it properly.

Disinfect the hands again with filtered 70% IPA. Allow to dry.

Enter in sterile corridor by pushing the door with elbow.

Disburse according to your work allotment in sterile area of manufacturing premises.

Exit Procedure: 

Airlock – IV

   After completion of the job, open the door of fourth air lock and enter in           

Airlock – IV.

    Remove the used sterile garments as laid down sequence.

Hand gloves

Foot wear

Booties

Boiler suit

Head gear

and put them in the bag and discard the set of dress in the “Used Linen           

Bin” provided in fourth air lock.

 Open the door of 1^St air lock and enter in it.  Put on the factory garments and foot wears.

Open the door of corridor and come out in non sterile corridor.

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The procedure for performing Bubble point test.

 Procedure for performing Bubble point test.

Procedure

Precautions And Instructions:

Bubble point testing of membrane filter assembly should be performed before and after aseptic filtration of the solution by manufacturing chemist, and record there of should be maintained in the B.M.R.

Requirements:

                              Bubble point test assembly.

Procedures:

Remove the sterilized membrane filter assembly in sterile area.

Attach sterile silicon tubing at both ends.

Fill 2 liters sterile water for injection in bubble point test apparatus.

Attach upper end of silicon tube to the bubble point test apparatus and lower end to another sterile glass flask.

Filter 2 liters of sterile distilled water through membrane using Nitrogen pressure.

Remove the upper silicon tube and attach Nitrogen tube to the upper end of membrane holder.

Gradually increase the Nitrogen pressure up to 25 PSI  (1.5 lbs) and check for 30 seconds.

No bubble should come out from lower end of lower tube (which is dipped in the sterile distilled water) and there should be no fall in pressure, 

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