i want to now about validation of sip and its defination
What is SIP???
Those equipment like holding vessels which are not placed in autoclave (due to size) for sterilization, then SIP (sterilization In Place) system is used, it a simple system and it contains following parts:
• Pure Steam Header
• Nitrogen/CA Header
• Condensate Manifold
• Diaphragm Pressure Gauge
• Sterile Safety Valve
• Temp. Sensor
• Temp. Indicator/controller (PLC Based)
• Pressure Transmitter
• Pneumatic Angle Diaph. Control Valve
• Pneumatic 3way Diaph. Control Valve
• Nitrogen Filter with Ball valve
• Steam Trap unit
• SS 304 Movable skid with castor wheel
• PLC Panel
THe SIP system connected with require vessel throgh pipe , then tank serve as a autoclave chamber.
For Qualification and sterilzation cycle development and validation , the almost same procedure is apply like autocave, mapping, distribution pnetration with and w/o BIs.
SIP means (sterilzation In place). It is a movible system which use to sterile the equipments.
What are the requirements for concurrent validation for injectables? is it neccesary to have the cleaning validation of the process?
Please specify and elloborate your question, concurent validation for what, process, system or other thing?
Cleaning validation is require for all products except those products which have dedicated equipment for manufacturing.
I mean concurrent validation for the whole process. Thanks
Yes, you can do concurrent validation of your existing products but for new products , you should initiate prospective validation.
SIP (Sterilize in Place) CIP (Clean in Place)
Learned quite a bit on CIP/SIP early in my career. These are both art forms. Since this is SIP, I will comment on that. IMO, the key to a successful SIP is trap sizing and placement. Traps too big and the steam escapes, too small and the condensate backs up thus cooling the tank. If you know anything about steam sterilization, then you know that air pockets can drastically effect the process. So do you attach a vacuum pump? or do you allow the steam to displace the air and vent out the top? How many places do you bring steam in, trap condensate, measure temperatures, place BIs? How do you thermal map a 10,000 L vessel? How do you cool the vessel when completed?
Oh here is the other big thing I learned, NEVER LET AN ENGINEER SHOW YOU A CALCULATION THAT CONDENSATE WILL FLOW UP. Do yourself a favor and slope the condensate lines down, even a little back pressure causes the traps to act erratically. And then you too can have some engineer waving his calculations in your face, claiming that it should work.