Yes When you are working under Grade A, you can also work in grade B but all activities under Grade A are aseptic simulation and must be done in media fill
Product design means developing a new product for patients which once finally developed, goes for exhibit batches and once approved by FDA , goes for commercial production
I have a doubt about a position in pharma, could you please make me understand, what are they actually talking about. What they actually need? Is it about instrument qualification/process validation/ or CSV ( computerised system validation). The role is experienced validation professional. About the job, are you an experienced Validation professional? Would you like to share knowledge with design manufacturing processes to optimize our existing Asceptic manufacturing (AM). Do you have experience in automating processes without compromising product quality?
There is nothing like reverse laminar air flow. Actually in RLAF, the air flow is sucked by return so as to not allow air to come out of LAF station to prevent material exposure in case of dispensing of raw materials. It is vertical air flow but sucked by suction so called reverse laminar air flow
Mainly Pharmacists and their seniors are responsible who prefer to sit in their cabin instead of visiting frequently aseptic processing areas and monitor the personnel hygienic practices. Hardly 1% Pharma companies may be having recordation of personnel monitoring rounds, incidents identification and CAPA.
You may need change control to prepare new media fill protocol and batch record. In case validation master plan does not define media fill requirements then you need to revise VMP to include media fill. Also, you need to have a SOP on how to perform media fill in detail
Then basically we are talking same process as cleaning validation involves to check if there are any product residue remains or not, and if present, should be within allowed limit, as MACO
Hi sir. Please make a video on Real Time Clock in HMI/PLC and its synchronisation with calibrated master clock. Also please explain about instruments connected to Server in Pharma Industry.
सर मेरा एक सवाल है Non- viable particle count करते समय 0.5 और 5.0 के size के ही particle क्यु count किए जाते हैं जबकि एरिया में और भी sizes के पार्टिकल मौजूद होते हैं जो प्रोडक्ट मे contamination कर सकते हैं
See this video In Hindi, What is D value, F value, Z Value? @PHARMAVEN #sterilization #validation #qualification ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-s58x6iMnllo.html
Already is there, see below link Depyrogenation Tunnel Working principle & validation #sterilization #usfda #aseptic @PHARMAVEN ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-ppeGHf8RtZs.html
There is no straight yes or no answer for this,. You need to investigate reason for that one sensor and if its sensor specific and not impacting overall sterilization then you can release but if it’s a system failure and sterilization cannot be assured then no
Very nice sir, agar kisi batch ka f0 value achieve nhi hua h to re terminal sterilization nhi krte h ok, to kya us batch ko hm market m dispatch kr skte h ??? Ya us batch ko reject krte h??
Sir, pls suggest....what will be the concentration of rioflavin used in CIP and what will be the drying time after sparying riboflavin. Is there any guidelines for this.
