Clean Room - Standards or some type of Clean Room Validation - ISO 13485

[azaplas]

Hi everyone,

I work for a laser company, and we just installed a Clean Room in our production area. Does anyone know if there are any standards or some type of Clean Room-Validation that needs to be done to conform with ISO 13485?

Where can I find information on Clean Room standards?

Thanks!

 

[Stijloor]

Re: Clean Room

Hi everyone,

I work for a laser company, and we just installed a Clean Room in our production area. Does anyone know if there are any standards or some type of Clean Room-Validation that needs to be done to conform with ISO 13485?

Where can I find information on Clean Room standards?

Thanks!

A search in the "Post Attachments" revealed this:

Clean Room Standards.

And of course Google can help too.

Stijloor.

 

[Jeff Frost]

Re: Clean Room

Two typically used standards are:

ISO 14644-1 Cleanrooms and Associated Controlled Environments - Part 1: Classifications
ISO 14644-2 Cleanrooms and Associated Controlled Environments - Part 2: Testing & Monitoring

 

[azaplas]

Re: Clean Room

Hi there, thank you for your responses. Are these required standards that must be abided by in order to have a cleanroom? Or can we have a cleanroom and have our own procedures in place even if they aren't following a specific ISO standard?

 

[MIREGMGR]

We don't know whether your need for a cleanroom pertains to particle-contamination avoidance for mechanical/electronic functionality, or sterile assembly, or sterile packaging. We also don't know the classification of your product; or its Intended Use; or whether it is sold as sterile, is post-sterilized by users, or need not be sterilized. These all would be germane in understanding how to answer your questions.

In general, both the EU (via ISO 13485 and the MDD) and the US FDA recognize ISO 14644 as a Consensus Standard. If either applicable regulations or your regulatory or validation stances call for a controlled-environment manufacturing space, that space should be certified to the appropriate class-level of ISO 14644.

 

[Ajit Basrur]

I can refer you to FDA Question and Answer on cGMP where it is mentioned that exclusive use of ISO 14644 is not expected and should be used in conjunction with other applicable standards.

6. Is it generally acceptable from a cGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying their facility?

No. It is generally not acceptable from a current good manufacturing practice (“cGMP”) perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 Part 1: Classification of Air Cleanliness (“14644-1”) and ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1 (“14644-2”) when qualifying their facility. Rather, a manufacturer of sterile drug products produced by aseptic processing should use these ISO standards in combination with applicable FDA regulations, guidance and other relevant references to ensure a pharmaceutical facility is under an appropriate state of control. Consequently, appropriate measures augmenting ISO’s recommendations (e.g., with microbiological data) would likely be expected for a firm to meet or exceed CGMP in a pharmaceutical facility.

Please understand that 14644-1 and 14644-2 have superseded Federal Standard 209E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones (“Federal Standard 209E”). In November 2001, the U.S. General Services Administration canceled Federal Standard 209E.

While not FDA regulations or FDA guidance, the Agency believes 14644-1 and 14644-2 are useful in facilitating the international harmonization of industrial air classification for non-viable particle cleanliness in multiple industries (e.g., computer, aerospace, pharmaceutical). As such, FDA adopted these particle cleanliness ratings in the 2004 guidance for industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. However, due to the unique aspects of producing sterile drug products by aseptic processing (e.g., microbiological issues) an aseptic processing manufacturer should not rely solely on 14644-1 and 14644-2 when qualifying their facility.​

ISO 14644 is a great standard consisting of various aspects involved in Clean Room.

ISO 14644-1: Classification of air cleanliness
ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-3: Test Methods
ISO 14644-4: Design, Construction, and Start-up
ISO 14644-5: Operations
ISO 14644-6: Vocabulary
ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments
ISO 14644-8: Classification of airborne molecular contamination

ISO 14644-9: Classification of surface particle cleanliness (Currently in Draft Stage)

 

[MIREGMGR]

My understanding of the FDA pharma rule cited by Ajit above is that it is a requirement for additional proven manufacturing-space environmental controls, over and above the appropriate level of 14644 compliance... because for clean aspects of pharma manufacturing, the FDA does not consider 14644 to be rigorous enough in the controls it requires.

I was under the impression that the original poster was asking about whether a manufacturing space could be considered a clean room if it either was engineered to a lesser level of performance than 14644 compliance would require, or perhaps was comparable to a 14644 compliant space but had not been certified to be so compliant.

 

[Ajit Basrur]

You are right MIREGMGR.

The OP asked if there is anyhting to be done for Clean Room-Validation to conform with ISO 13485, the answer is that ISO 13485 standard is a QMS and doesnot tell how to do validation.

For validation, ISO 14644 standards can be used as a base and applicable FDA guidelines to be referred.

 

[azaplas]

We don't know whether your need for a cleanroom pertains to particle-contamination avoidance for mechanical/electronic functionality, or sterile assembly, or sterile packaging. We also don't know the classification of your product; or its Intended Use; or whether it is sold as sterile, is post-sterilized by users, or need not be sterilized. These all would be germane in understanding how to answer your questions.

Hi there, thanks for your responses! Yes, we installed the cleanroom for particle-contamination avoidance for mechanical/electronic functionality. We're not using it for pharmaceutical/sterile procedures. The product is a Class II device class, and a Class IV laser. We're using the cleanroom for assembling the PCB boards that go into the lasers. The product does not need to be sterilized.

So since we installed the cleanroom, we need to conform with ISO 13485 by becoming ISO 14644 certified? We were 13485 certified before we installed the cleanroom; does the additional of the cleanroom put new requirements on us regarding the cleanroom?

Does anyone happen to know if there are FDA requirements for having a cleanroom? I did see that they cancelled the FED-STD-209E and now recognize the ISO 14644 standards, but are these requirements?

Thanks!

 

[Jimmy the Brit]

If you are making devices that are either to be sterilized, or require some degree of bioburden control, I recommend that you also have a look at the following.

ISO14698 Cleanrooms and associated controlled environments — Biocontamination control

Part 1: General principles and methods​

Part 2: Evaluation and interpretation of biocontamination data

For bacterial monitoring don't get hung up following the ISO14644 NL = √A sampling plan, but choose your sites based on contamination risk.

If you are not concerned about viable particles then don't worry about it.

Jim