utilities

Clean Steam

Introduction
The quality of the steam supplied to autoclaves and Steam in Place (SIP) equipment can have a major influence on the efficacy of sterilisation process, quality of the sterile product and longevity of the sterilizers, SIP equipments and its associated equipment.

Clean Steam is steam whose condensate meets the specification for Water For Injection (WFI), USP, EP. The WFI specification is applied to the clean steam condensate to ensure that product contact surfaces in contact with the steam are not contaminated during the sterilisation process. Water used for the manufacture of parenterals has to conform to USP / EP requirements.

The quality of the compressed air and special gases supplied to process equipment can be critical, especially when it is used in an aseptic environment and / or involves product contact. An oil-free compressed air system is usually specified for production areas and generally consists of an oil-free compressor, dryer, storage tank and distribution system. The Pharmaceutical and Biotechnology industries are heavily dependent upon Nitrogen gas and the quality of the nitrogen gas supplied to process equipment can be critical, especially when it is used in an aseptic environment and may involve product contact.

Approach

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

We are able to assist in the qualification of generation and the distribution of the clean steam systems, water generation, (pre-treatment & purification), storage and distribution systems and the qualification of compressed air supply and distribution systems.

We are able to carry out Steam Quality Testing in accordance with EN285 and HTM2010

For the usage of the gas that may come in contact with APIs or pharmaceutical substances, users are obliged to conform to strict regulations, (current good manufacturing practice (cGMP) regulations). We are able to assist in the qualification of Nitrogen gas supply and distribution systems.

Experience

PEV staff are experienced in the validation of clean steam systems. We understand the critical factors in generation and distribution of the clean steam such as feed-water quality, steam generator design / operating parameters and distribution system design.

We are experienced in the validation of Purified Water and WFI systems. We understand the required water quality can be dependent on special “in-house” process requirements as well as the pharmaceutical product and the specified compendial limits, (chemical, microbial, and endotoxin).

We are experienced in the validation of oil-free compressed air systems. We understand the critical factors in the generation and distribution of the compressed air system, such as compressor design / operating parameters, component suitability, and for distribution system quality testing requirements (dryness , particulate contamination etc).

We are experienced in the validation of special gas systems and our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities. We understand the critical factors in the generation and distribution of the system, such as safety verification, operating parameters, component suitability, and, for distribution systems, quality testing requirements (particulate contamination etc).

We can provide operational resource and assistance with the generation of User Requirement Specifications (URS), through Factory Acceptance Testing (FAT) to Site Acceptance Tests (SAT) and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).