SencorpWhite Offers Industry’s First Medical Pouch Sealer/Cutter
SencorpWhite (Hyannis, MA) has announced the industry’s first sealer/cutter systems – the CeraTek 12-MPK/2 and 24-MPK/2. In adding cutting capabilities to the CeraTek product lines, these systems allow medical device manufacturers to combine medical pouch sealing and cutting processes into one step following sterilization.
Instead of the typical “seal, send out for sterilization, bring back for the secondary seal, and cut off the header” process, the systems allow the operator to seal and cut off the pouch header on the same machine in a one process step. In addition to saving time and money, the system also improves the quality and repeatability of the process.
Medical device companies will benefit from a precise, repeatable heat seal and cutting capability that will have a positive impact on the validation of their entire sealing process, the company said.
The systems are CE compliant, clean room wash down compatible, and ISO 11607 compliant.
The CeraTek 12-MPK/2 has a 12 inch long seal die and can accommodate an 11.5 inch pouch; the 24-MPK/2 has a 24 inch long seal die and can accommodate a 23.5 inch pouch.
Medical device manufacturers or contract manufacturers can gain the following benefits:
Superior seal quality with a cleaner more consistently located cut;
Shorter process time/less handling by combining the seal and cut into one step;
Pouches that are easier to ship and store after the header is removed;
The ability to use one size pouch for multiple size products.
Primarily targeted for header pouch applications, the CeraPak 12-MPK/2 and 24-MPK/2 sealer/cutters deliver a range of advantages. The cutting mechanism can be activated or deactivated during the seal cycle, allowing the machine to be used as a sealer/cutter or a straight sealer for multiple process steps or applications. The cutting mechanism timing is recipe driven; the cut can be made upon seal cycle initiation, at any point during the seal cycle, or after the seal cycle is completed. A cut delay time is input to the recipe via a standard touchscreen HMI. Different scrap bin options are available.
Header pouches are primarily used for oxygen and/or moisture sensitive products. They incorporate a breathable header window with a barrier film for the main pouch body and they are typically sterilized using gas, such as EtO (Ethylene Oxide). The pre-sterilization seal is made at the very top (above the header) and the secondary post-sterilization seal is made below the header. It is important to have a quality seal with no wrinkles.