Utilities

Introduction

The quality of the utilities supplied to process equipment can be critical when used in an aseptic environment and / or involve product contact. Users must comply with cGMP regulations for such utilities.

Water is often deemed to be a critical utility. Water has to conform to the appropriate specification, e.g Water for Injection (WFI).

Clean Steam is steam whose condensate meets the specification for WFI. This specification is applied to the clean steam condensate to ensure that product contact surfaces are not contaminated during the sterilisation process. The quality of the steam supplied to autoclaves and Steam in Place (SIP) equipment can have a major influence on the efficacy of the sterilisation process and the longevity of the associated equipment, as well as the quality of the sterile product.

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. Air that is required to be sterile is usually filtered close to the point of use.

Nitrogen gas supplied to process equipment is usually deemed to be a critical utility and is also sterile filtered.

Approach

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

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

We perform Steam Quality Testing in accordance with EN285.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary and clear conclusion.

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 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 help with the generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews.

We perform Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.