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. The units 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.
ETC provides the most comprehensive and integrated documentation scope in the industry. Documentation is fully compliant with GAMP5 leading to streamlined FAT, SAT, IQ, OQ and PQ execution translating to considerable validation cost savings. Beginning with the client URS and generation of a QPP and FRS internally on to the change control documentation available with all cGMP systems the integrated approach maintains a completely connected product life cycle path.
Highlights
"One Step™" Sterilization-Drying Process:
ETC's special sterilizers with the patented "One Step™" Sterilization-Drying Process help pharmaceutical companies solve a costly, industry wide problem: wet product on completion of the sterilization cycle.
ETC's "One-Step™" sterilizers solve this problem and cut production costs by:
- Reducing typical cycle times from 10 - 14 hrs to 4 - 6 hrs.
- Increasing productivity, product is ready for immediate use.
- Eliminating the need for expensive drying ovens.
- Saving drying oven validation costs.
- Saving utility & maintenance costs associated with oven operation.
- Reducing additional product handling and the potential for contamination (product stays within the sterilizer).
An ETC "One Step™" sterilizer can be used in any process application where loads are difficult to dry prior to the end of the cycle or where additional drying is performed by using specialty ovens. Products such as those listed below can easily be processed using the "One-Step™" process:
- Line Seals, Caps, or Rubber Stoppers packaged in permeable bags
- Dialysis Filters & Filters in permeable bags
- Carboys
- Tubing
