1. Which test should to be performed to detect the leakage & penetration of steam in Steam sterilizer/ Autoclave?
Answer: The identification for any leakage & penetration of steam can be tested by the following methods: Chamber Leak Test, Bowie-Dick test
- Mention the name of all the utility required to run the steam sterilizer/ Autoclave.
Answer: Plant Steam for Jacket, Pure Steam for Chamber, Soften Water for Vacuum System, Compressed Air
- How many temperature probes are inside the chamber of steam sterilizer/ Autoclave?
Answer: Five Numbers
- Mention the name of all different zones in Sterilization and Depyrogenation tunnel.
Answer: Dry zone, Hot Zone (Sterilization zone), Cool zone
- Mention the utility requirement for run the Ampoule/Vial washing machine.
Answer: Purified water, WFI, Compressed gas
- Write down the steps of the washing cycle in Ampoule/Vial washing machine.
Answer:
Station1: Initial washing of the Ampoules with Recirculated WFI for internal and external surfaces.
Station2: Drying of washed Ampoules after washing with filtered compressed air for internal surfaces.
Station3: Further washing of the Ampoules with purified water for internal surfaces.
Station4: Drying of washed Ampoules after washing with filtered compressed air for internal surfaces.
Station5: Further washing of the Ampoules with WFI for internal and external surfaces.
Station6: Final drying of internal and external blow-dry with compressed air for internal and external surfaces.
- Why Pre-post nitrogen gassing is required during Ampoule filling operation.
Answer: To maintain sterility and remove air from the ampoule
- Mention the name of gas required to adjust the flame in Ampoule filling machine.
Answer: LPG & oxygen
- Mention the type of filter used in Lyophilizer
Answer: Hydrophobic or Air filter 0.22 micron
- Mention the all different steps of Lyophilization procedure.
Answer:
- Clean In Place
- Steam In Place
- Leak Rate Test
- Shelves Pre-cooling and Loading
- Freezing
- Primary Drying
- Secondary Drying
- Backfilling If Applicable
- Release
- Defrosting
- Cleaning
- Describe briefly the CIP/SIP procedure in Lyophilizer
- Mention the name of tests require for filter integrity of wet and air vent filter.
- Wet filter – FF/BP
- Air vent – WIT
- Mention the name of major change part in vial filling and stoppering machine.
- Why “Shelf Uniformity TEST” test performed during validation of lyophilizer
Answer: The purpose of this test is to verify that the temperature across an individual shelf and from shelf to shelf is significant.
- Mention few “Alarms and Safety interlocks” in Steam sterilizer
- Mention few “Alarms and Safety interlocks” in Vial/Ampoule washing machine
- Mention few “Alarms and Safety interlock” in Depyrogenation tunnel and filling machine
 in parenteral injectable plant ){kind=link}
3 Comments
Nice portrayed article. I believe it's sufficient to find out about this subject. Much obliged for sharing a particularly magnificent article. Continue to share new themes each day.
ReplyDeleteOutside tap
I feel that you simply could do with a few p.c. to power the message home a bit, however other than that, this is magnificent blog. A great read. I will certainly be back.
ReplyDeleteBosch Washing Machine Repairs
Miele Dishwasher Repairs
If your Washing machine, Dishwasher or Dryer has stopped working, you need professional help. This is where we step in to repair your appliances.
ReplyDeleteWith all the experience and expertise, we are a service to rely on. For an extended life of an appliance, its maintenance is important. However, if your appliance is causing trouble, we are here to provide any Miele Dishwasher Repairs.