Suction device for crimping station?

GOOD ENGINEERING PRACTICE (cGEP)
1

In EU GMP guide, Vol4, Annex1 is stated:
“119. As the equipment used to crimp vial caps can generate large quantities of non-viable particulates, the equipment should be located at a separate station equipped with adequate air extraction.”

Does that mean there must be some additional suction device for air extraction OR can be air extraction assured by sufficient air flow (from LF hood above crimp station) which flush particles out of LF hood?

Thanks for your comments!

2

This gives a guidance about 2 major points:

  1. You should have a speration of equipment and seperation of zones between your Filling/ bunging area and Crimping section or sealing section.

2.You should have a proper laminar flow system to flush particles and the air pressure in the Filling/bunging zones should always be higher by 1000CFM than the crimping zone so that such dust or particulate matter does not enter the crtical zone.

You need not have a dust extractors here. Vial seals/crimps shall be dedusted as per procedures and they are either sterilized or sanitized(depending up on company procedure or regulatory requirement in particular country) and shall be properly passed into respective areas in a bin or a container. Initial particulates are taken care. Since this is not an Oncology operation you need not have a dust extractor if your dedusting procedures are excellent and also you should defend them infront of an Regulatorry Auditor during inspections.

Regards