Cleanroom Packaging: 10 Questions to Ask

In today's competitive market, many outsourcing companies claim to run top-of-the-line cleanroom facilities for packaging sterile medical devices. But not all cleanrooms are the same.

It is important to understand that fundamental differences exist between cleanrooms for medical device manufacturers and cleanrooms for manufacturers of machinery, optical products, high-end electronics, and other devices not intended to penetrate the skin or interact with open wounds.

Since quality is a key factor in the success or failure of many medical device manufacturers, how does a medical device maker search out a facility that packages a product to current rigorous standards? This article presents 10 questions that medical device manufacturers should ask potential partners and themselves when choosing a cleanroom service provider.

1. Does the cleanroom actually exist, or is it simply a marked-off area?

2. Is the cleanroom fully integrated into the quality system?

3. Does the cleanroom's layout promote efficiency and reduce biocontamination?

4. Is cleanroom maintenance a priority?

5. Is a validated ultrasonic clean line attached to the cleanroom?

6. Has the cleanroom been audited multiple times?

7. Is the cleanroom staffed with experienced sterile packaging technicians?

8. Is testing paramount?

9. Does the cleanroom run a particulate-monitoring system?

10. Do I trust this company?