ASEPSYS systems are designed and constructed to produce purified water in full compliance with cGMP guidelines as per FDA and EMEA, EP, JP and USP requirements for pharmaceutical, laboratory and medical applications.
Purified water is used as an excipient in the preparation of non-sterile products and as a starting material in the preparation of water for injection and pure steam. It is also used for rinsing purposes and in the preparation of cleaning solutions.
Purified water is used in the preparation of medicinal products where bacterial endotoxins need to be controlled, except where water for injection is required.
Engineering and manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and construction meets the most stringent Regulations and Codes from Europe, USA and others concerning Safety and Pressure Vessels.
To ensure the equipment meets your requirements, we work in partnership with you, a dedicated team follows your order as a unique project. We develop specific Quality Plans (DQ, IQ and OQ) and undertake factory acceptance testing (FAT) to give assurance of performance and quality.