Clean Room as a Controlled Environment - Requirements

[Rooster69]

Here is the Medical Device Regulatory Compliance Correlation Matrix. ( Cheat Sheet )

 

[Ronen E]

Unfortunately MDD annex I s. 8 sheds no additinal light WRT the questions above:

8. Infection and microbial contamination

8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use.

8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues.

Notified bodies shall retain information on the geographical origin of the animals.

Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.

8.3. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.

8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.

8.5. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions.

8.6. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer.

8.7. The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.

 

[TWA - not the airline]

You have to keep in mind that the bioburden is related to the sterilization validation, i.e. your sterilization validation only stays valid as long as the amount and type of germs on your devices (after manufacturing/before sterilization) are the same as during the validation runs (the validation should state detailed acceptance criteria regarding that issue). Now, that does not directly mean you need to control the bioburden in your clean room, but then typically you need to do more monitoring on your finished devices. If you monitor your clean room more closely and have a good link between the bioburden of the clean room and your product then you can reduce the bioburden testing on finished devices, which will save you some money and also alert you much more ealier if something gets out of control...