Thermoformed medical packaging, like medical device trays, blisters, kits, and assembly trays, can be manufactured in a cleanroom or standard production facility. The main difference is that cleanrooms are sterile, controlled environments, where airborne particulate is monitored, and bio burden agents mitigated.
The cost of cleanroom medical packaging exceeds that of standard production packaging because one is investing in quantifiable assurance that the thermoformed package will meet the requirements for medical device safety and efficacy.
In order to provide a sterile environment for manufacturing medical packaging, investments in new equipment, materials and procedures must be made; understanding these helps provide guidance when deciding which manufacturing environment is appropriate for your medical device or product.
Dordan's ISO class 8 cleanroom for thermoforming medical packaging