The term grade A air supply is specifically used to describe a supply of air which is HEPA filtered, and at the point of supply meets when tested, the non-viable particulate requirements of a grade A area, as defined in paragraph 4 of the revised Annex 1. It is important to differentiate between the terms grade A air supply and PI 032-2 "GMP Annex 1 Rev. 2008 Interpretation of Most Important Changes for the Manufacture o Sterile Medicinal Products" (page 10) grade A area. A grade A air supply should be qualified and monitored as follows:

"Qualification requirements:

• Qualification is done only under at rest conditions: For the crimp-capping machine the at-rest state is achieved when the air supply is switched on, the crimp-capping machine is operating (feeding of vials and crimp caps is not considered necessary) and there is no interference by operators. For the conveyor tunnel for liquid products the at-rest state is achieved when the air supply is switched on, the conveyor belt is switched on and there is no interference by operators.
• Non-viable particles should be measured and are expected to meet grade A requirements. The probe should be located at the point of supply of the filtered air.
• Smoke studies should be performed. Whilst unidirectional air flow is not required, efficient protection of the vials should be demonstrated and the absence of air entrainment from the surrounding room should be demonstrated.
• Limits for air velocity should be in place and justified.

Monitoring requirements:

Monitoring requirements for non-viable particles and microbiological contamination should be defined by the company following a risk assessment."

Outcome:

Note the new term mentioned in Annex 1 of the EU GMP Guide and its definition provided by PIC/S. Check your SOPs, facilities and processes being in accordance with the new term.

Link:

PI 032-2 "GMP Annex 1 Rev. 2008 Interpretation of Most Important Changes for the Manufacture o Sterile Medicinal Products"