Sepha’s EZ Blister+ is a compact small-batch blister packaging machine that is 21 CFR Part 11 compliant.
Sepha’s EZ Blister+ is a compact small-batch blister packaging machine with a software architecture that has demonstrated compliance with 21 Code of Federal Regulations Part 11. The EZ Blister+ is built to deliver small batches of drugs and medical devices with electronic signatures, batch reports, audit trails, and other forms of electronic documentation.
The blister trays are either thermoformed or coldformed, sealed with pre-cut pieces of lidding material using knurled or flat-heated sealing plates, and then cut and perforated using a precision die-cutter. The EZ Blister+ can package tablets, capsules, ampoules, and various other products.
Additionally, the machine’s structured query language database system powers various functions while also facilitating integration with factory networks and management execution systems.