Hello everybody,

I am quite new to this forum and have some burning questions;

1. We are just in the phase of setting up a cleanroom and trying to find a justification that you can use an ISO 7-8 cleanroom for the production of medical devices. Does somebody know where I can find this justification? It is not in the ISO 14644.

2. We have bought an air compressor to use with appartus in the cleanroom (hole punchers, insert-molders, tipping machines etc.) What are the criteria there? what filtering should I use on that machine? Should I undertake special measures not to disturb airflow?

Please help me out here, I am a real newbie

The regulations such as FDA do not indicate what environmental, product, or facility parameters to control. The regulations provide only the standards a company must meet after it decides to manufacture the product in such an environment.

FDA does not determine whether a company should manufacture a given product in a cleanroom environment.

Refer to the FDA GMP for the Medical Devices (21 CFR Parts 820 – Quality System Regulation), the section 820.70-production and process control stated….
(c) Environmental control. Each manufacturer shall establish and maintain requirements for the environment to which product is exposed. Where environmental conditions could have an adverse effect on a device's fitness for use, these environmental conditions shall be controlled, and procedures for such controls shall be established and maintained. Any environmental control system shall be periodically inspected to verify that the system is adequate and functions properly. Results of such inspections shall be documented and reviewed.
(f) Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.

If all companies producing a similar product did so in a Class 10,000 cleanroom, then a competitor applying for approval would also likely need to have a cleanroom. Practices by other manufacturers often set the standards for environmental and process specifications.

You may need to take some professional guidance because you are getting into areas where lack of knowledge could expose you to people like the FDA who allow no deviations and take no prisoners in the manufacture of controlled materials like medical devices.

Basically ISO 7 is OK for things like catheters and stents but you also need to control the bioburden by taking swabs and using agar plates. Bacteria is the big issue and its controlled by the various Health bodies who usually refer to the "orange book", the US pharmacopea or the EU GMP guide to good manufacturing Practice (GMP) . 

They have 4 types of room,  Grade A,B,C and D and generally  follow the 14644 ISO levels but they also insist on measuring 5 micron particles. 20 /cu mtre grade A , 29 B , 2900 C and 29,000 for D. with 0.5 micron rates of 3,520, 3520, 352,000 and 3,520,000 per cu metre. Therfore grade A needs continual particulate monitoring and grade B is usually turbulent so compressors can be used. However they would have to be oil free to a very fine level and all cylinder exhausts need to be piped out the room.

Theres a mass to do and without experience your man is heading for disaster

Regards,
Dick Gibbons (committee member of the BSI LB I 30 in the UK and convenes 14644 part 8 and 10 for Chemical contamination)

You may need to take some professional guidance because you are getting into areas where lack of knowledge could expose you to people like the FDA who allow no deviations and take no prisoners in the manufacture of controlled materials like medical devices.

Basically ISO 7 is OK for things like catheters and stents but you also need to control the bioburden by taking swabs and using agar plates. Bacteria is the big issue and its controlled by the various Health bodies who usually refer to the "orange book", the US pharmacopea or the EU GMP guide to good manufacturing Practice (GMP) . 

They have 4 types of room,  Grade A,B,C and D and generally  follow the 14644 ISO levels but they also insist on measuring 5 micron particles. 20 /cu mtre grade A , 29 B , 2900 C and 29,000 for D. with 0.5 micron rates of 3,520, 3520, 352,000 and 3,520,000 per cu metre. Therfore grade A needs continual particulate monitoring and grade B is usually turbulent so compressors can be used. However they would have to be oil free to a very fine level and all cylinder exhausts need to be piped out the room.

Theres a mass to do and without experience your man is heading for disaster

Regards,
Dick Gibbons (committee member of the BSI LB I 30 in the UK and convenes 14644 part 8 and 10 for Chemical contamination)

I agree with you that this scenario is very sensitive. So you will need to gather more pertinent information and guidelines in medical devices. Absolutely, it doesn't need an impromptu but requires planning to prevent from risks or threats.