Regulatory Open Forum

 View Only

  • 1.  Clean Room Requirements

    Posted 20-Apr-2020 11:53
    Hi
    For devices that are provided sterile, can the manufacturer determine the clean room requirements based on requirements that need to be met for  sterilization validation and biocompatibility? In other words if the device consistently meets biocompatibility and sterility requirements then is manufacture in a clean room required for all phases of manufacturing? 

    ------------------------------
    Ann Kemp RAC
    Consultant
    Saint Paul MN
    United States
    ------------------------------


  • 2.  RE: Clean Room Requirements

    Posted 21-Apr-2020 03:58
    Hi Ann,

    The regulation mentions that sterile product must be manufactured in an appropriate controlled environment. Nothing more (unfortunately).
    ISO 14644 series provide guidelines for the cleanroom, but not exactly which procedures must be performed in which cleanroom classification. The diversity of the devices and the wide range of manufacturing procedures makes it impossible to create such guidelines.
    The are some general acceptable rules among the auditors, but you cannot count on that.

    I believe that your approach must be based on a risk assessment of the manufacturing procedure. I do not think biocompatibility must be included because it is once off testing and not routine monitoring. You should include environmental monitoring and define the critical phases of the procedure, in order to define the requirements.

    I do not think that you will receive a straightforward answer from anyone. If you do, it will probably be inaccurate.

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 3.  RE: Clean Room Requirements

    Posted 21-Apr-2020 04:29
    Hello Ann,

    The answer to your question really depends on your device, classification of device, is it an implant, and sterilisation process.  There is some white papers and technical papers published over the years on clean room qualification which has topics on selection and requirements of cleanroom based on finished device.  As you can imagine there is a lot more information about cleanrooms, selection of cleanroom (ISO 7 or 8), and additional aspect like environmental monitoring and biocompatibility.  What I can say there is expectations for certain levels of cleanrooms or types of cleanroom based on the product type.  I am not sure it is written down anywhere, but maybe ... as example sterile implants often are finished and packaged in ISO Class 6 or 7 cleanrooms again depending on the device.  Your best bet is to get an SME in environments around medical devices and conduct an assessment.  Or if you already have something in place, a nice review is helpful during an routine review of process or re-validation needs.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Clean Room Requirements

    Posted 21-Apr-2020 14:57
    To build on the current replies, what I would say is that if you do NOT manufacture in a cleanroom, the control of the environment (and thus the potential effect on the final product)  becomes less predictable.  With cleanrooms come a certain level of testing an ongoing monitoring.  On the other hand, i have worked in manufacturing settings that are not cleanroom certified, but are "controlled", with a level of monitoring being done that showed predictable results and allowed for control when changes were made in the room, and that has sufficed.   

    Jackie

    ------------------------------
    Jackie Torfin
    Vice President, Global QA and Regulatory Compliance
    Maple Grove MN
    United States
    ------------------------------

    Original Message


Related Content