If you need parts molded, assembled and packaged in a cleanroom we've got you covered. We have nine ISO Class 8 and three ISO Class 7 cleanrooms for medical device manufacturing and medical seal packaging. We also offer validated part cleansing processes. The cleanrooms are certified to ISO Class 7 standards for sterile barrier packaging and ISO Class 8 standards for molding
We have two different types of sealers: Impulse sealers, which use a pressure bar and heat to seal the pouch and Band sealers (or rotary sealer) that use a belt to pull the pouch through heater bands to create a seal.
Tyvek/LDPE pouches are the standard pouch we offer, and they come in various standard sizes but can also be custom sized and with custom printing or labels attached. If you require a different material for your packaging, we are willing to work with you to make that happen.
We can also print directly on the pouch (for example dates, lot numbers, expiration dates).
P1 Technologies can manufacture a part for a customer, package it and have it dropped shipped to a sterilizer.
We test our seals with peel/burst tests that are performed periodically through a production run.