ETC provides a comprehensive range of standard and customized cGMP Sterilizer types, sizes and configurations. cGMP Sterilizers are precision engineered and manufactured for regulatory compliance, high performance, ease of use, reliability in service, extended life and maximum value. They are PLC controlled with an advanced user interface, providing flexibility of cycle programming and visually intuitive cycle selection. Systems are predisposed for Title 21 CFR Part 11 electronic records and signatures compliance.

Sterilizers are designed for compliance with current cGMP regulations, ISA S88 batch process specifications and GAMP5 automation requirements, translating to efficiency in performance, commissioning and validation. All sterilizers are configured for use in pass-through or single sided operation and are available with a wide variety of door configurations and accessory components for product load management, and optimized utility use.

ETC’s rigorous ISO-9001 Quality System and adherence with GAMP5 Quality and project plans ensure that all functionality, testing, and documentation meet or exceed cGMP guidelines enabling ease of validation. Control systems interfaces are 21 CFR Part 11 Compliant.

Some of our clients past and present include: AstraZeneca, Baxter, Bayer, Beckton, Dickinson, Boston Scientific, GSK, Johnson & Johnson, Merck, Novartis, Schering, Plough, and Wyeth.