What is requirement for the background grade for capping machine (capping in Grade A)?
Is Grade C enough for background area?
Has particle monitoring to be performed during whole capping process under Grade A?
In my opinion Grade C background should be sufficient and also monitoring of particles during full duration of capping not necessary because capping is not critical sterile operation - vials are already fully stoppered before entering capping machine.
Am I right?
Thanks for your reply!
As far as EMEA guidance Annex II is concerned you need to cap your vials under LAF with a back ground area B. This came into enforcement around March/April 2010. This is for Lyophilized Bio products, Pharmaceutical Parenterals.
There was always a debate on this issue because in such an area you need always to treat the Caps or Seals in same way your sterilize the rubber bungs by removing particulates and rendering them sterile.
The air particle requirement in such casses fall same as filling area.There is no change.
Well Grade A laf housed in Grade C area is good. But it all depends in which country your area manufacturing or which country you are exporting.
Regards
I wrote in the above post as Annex-II and it must be corrected as Annex-I.
Part IV Buildings and Design, section E “Design” of the FDA Aseptic Guide from September 2004 states: “If stoppered vials exit an aseptic processing zone or room prior to capping, appropriate assurances should be in place to safeguard the product, such as local protection, until completion of the crimping step. Use of devices for on-line detection of improperly seated stoppers can provide additional assurance.”
According to the Annex 1, the key point is to safeguard the product prior capping. Therefore the standard process capping with laminar flow in clean room Grade C was reassessed.
The core concern of the concept is the need to ensure the integrity of the containers. The specification was that the packaging combinations must be microbiologically sealed even without crimping caps. On one hand, this requires developing and optimising suitable packaging combinations; on the other hand it requires adequate process know-how, and finally ensuring a suitable process control concept.
For this concept the fundamental questions are:
How to test microbiological tightness?
How to handle packaging deviations and how to test the worst case combination?
Which process control tools are necessary and suitable?
To address the microbiological tightness, a stronger and easier measurable criterion, the gas tightness, was defined. Therefore, various methods were used during packaging development to define the parameters for “gas tightness” of the packaging combinations. Methods used are frequency modulated spectroscopy (FMS) and the helium leak test, whilst the methylene blue dye ingress test was used to check the tightness of the stoppered vials.