English
  • page_banner
GMP ISO Class 100000 Medical Device Clean Room Featured Image
  • productmedical device clean room
  • productclass 100000 clean room
  • productclean room
  • productcleanroom
  • productgmp clean room
  • productsterile clean room

GMP ISO Class 100000 Medical Device Clean Room

Short Description:

Medical device clean room is mainly used in syringe, infusion bag, medical disposable goods, etc. Sterile clean room is the base to make sure the quality of medical device. The key is to control production process to avoid pollution and manufacture as regulation and standard. Must do clean room construction according to environmental parameters and monitor regularly to make sure clean room can reach design and usage requirement.


Product Detail

Product Tags

Product Description

Medical device clean room has developed rapidly, playing an important role in improving product quality. Product quality is not finally detected but is produced through strict process control. Environmental control is a key link in production process control. Doing a good job in clean room monitoring is very important to product quality. At present, it is not popular for medical device manufacturers to carry out clean room monitoring, and companies lack awareness of its importance. How to correctly understand and implement the current standards, how to conduct a more scientific and reasonable evaluation of clean rooms, and how to propose reasonable test indicators for the operation and maintenance of clean rooms are issues of common concern to enterprises and those engaged in monitoring and supervision.

Technical Data Sheet

ISO Class Max Particle/m3 Max Microorganism/m3
  ≥0.5 µm ≥5.0 µm Floating Bacteria cfu/dish Depositing Bacteria cfu/dish
Class 100 3500 0 1 5
Class 10000 350000 2000 3 100
Class 100000 3500000 20000 10 500

Project Cases

medical device clean room
clean room
clean room project
clean room design
clean room construction
class 100000 clean room

FAQ

Q: What cleanliness is medical device clean room required?

A: It is usually ISO 8 cleanliness required.

Q: Can we get a budget calculation for our medical device clean room?

A: Yes, we can give a cost etimation for the whole project.

Q: How long will medical device clean room take?

A: It is usually 1 year needed but also depends on work scope.

Q: Can you do overseas construction for clean room?

A: Yes, we can arrange it.

  • Previous:
  • Next:

    • Related PRODUCTS