British Standards Institution

Source:: CEN
Committee:: LBI/30 - Cleanroom technology
Categories:: Information management | Standardization. General rules | Environment | Air quality | Cleanrooms and associated controlled environments

Scope

This standard will establish recommendations and methodology for demonstrating microbiological contamination control in cleanrooms and clean controlled environments. This standard will be limited to viable microbiological contamination control and excludes any considerations of endotoxin, prion and viral contamination. This standard provides guidance for common applications, including Pharmaceutical, Biopharmaceutical, Medical Device, Hospitals and Food.

Purpose

Draft decision 001/2022 on NWIP to accept VA/ISO lead for ISO 14644-20

Comment on proposal

Required form fields are indicated by an asterisk (*) character.

How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

Discard

Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

30/09/2022

Proposal end date:

14/11/2022

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

Draft decision 001/2022 on NWIP to accept VA/ISO lead for ISO 14644-20 - Cleanrooms and associated controlled environments — Part 20: Microbiological contamination control

Scope

Purpose

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error