Does anybody know if the NSF certifications of oil and greases that might be in contact with phamaceutical raw material, are acceptable by the FDA?
all equipment manufacturers make their recommendations on lubricants for use in manufacturing processes. A process manufacturing method sheet must include approved and accepted lubricants in their maintenance and PM procedures, the proper use of these and an accompanying MSD sheet. The approved lubricants require proper handling around process products and materials. Procedures must exist for maintaining and clean-up when lubricants, detergents, solvents and other chemicals are used around a process or machine. These have had to be captured in the IQ of the equipment. If an MSD does not exist and a PM procedure does not mention it, it should not be used!
Your IQ should verify that all lubricants used around and on a piece of equipment conform to the requirements detailed in CFR’s. (inadvertent contact)
This is the only instruction from the FDA. No single grease or oil is ‘APPROVED’. A list of component parts is agreed and it is up to the lubricant manufacturer to certify that their lubricant is manufactured using the ingredients listed in CFR number?
One lubricant that you will often see around labs and autoclaves is WD40, which is none compliant and should never be in a manufacturing area.
Want to know the CFR’s, send me an email.
During qualification of compressed air particle count is required ? if yes then generation or point of use , for how many days and any reference for that?
[quote=himanshumb]During qualification of compressed air particle count is required ? if yes then generation or point of use , for how many days and any reference for that?
Air particles monitoring must be perform during qualification phase as well in regular production. In qualification stage, all the points must be cover including system component points as well all user points but in regular production, it depends on comapny policy.
Thanks , Any refferance.
[quote=himanshumb]Thanks , Any refferance.
Validation studies must be design logically, scientifically and justified, There are some references available but you can design studies yourself according to conditions.