OP Masks - produce competitively

The production of masks of all kinds during these times of the Corona crisis is developing into a lucrative business for various manufacturers who want to dedicate themselves to this topic. At the same time, there is a great lack of knowledge and uncertainty about the extent to which and which masks are subject to the Medical Device Directive. In EU Directive 2017/745 on Medical Devices (EU MDR Medical Devices Regulation), which supersedes Directive 93/42/EEC, it states in Annex I Chapter II Point 11.6.: Products that are to be sterilized are manufactured and packaged under appropriate and controlled conditions and in appropriate and controlled facilities.

Even if, due to the current SARS-CoV-2 pandemic, the European authority proposed in the Official Journal of the EU on April 3, 2020 (CELEX number: 52020PC0144) to postpone the start of validity of the new MDR regulation 2017/745 by one year, the groundwork is already being laid for long-term production, especially of surgical masks. Suppliers of cleanroom technology are being approached by many manufacturers to create a cleanroom in the shortest possible time.

This question touches on one of the fundamental problems of cleanroom technology, which is that it is primarily thought of in terms of "rooms" rather than "processes." Why should the automatic machines for mask manufacturing necessarily be located in a cleanroom? A local machine enclosure with appropriate filter technology is completely sufficient. Here are just a few advantages of enclosure versus a cleanroom:

• Only the machine and the process inside it are supplied with clean air, not a large unused volume that automatically occurs in a cleanroom.
  - The operating personnel are completely outside the production area. Cross-contamination from neighboring machines and personnel cannot occur.
  - The achievable cleanliness on the product is higher than what is possible in a cleanroom.
  - The machine enclosure is essentially a part of the machine and can be easily taken along when moving to other production areas, which is either not possible or only with greater effort in a cleanroom.
  - Changes to the machine (additional process stations, a changed process flow, etc.) can be implemented with minimal effort through modification and/or enlargement of the machine enclosure. Is the cleanroom too small...?
  - The investment costs, ongoing costs, and delivery times for the machine enclosure are significantly lower than for a cleanroom.
  - The ongoing costs are reduced to the same extent.
  - The possible delivery times are shorter than for a cleanroom.