Utilities: key points for URS and validation

Control of Environment of Manufacturing and Control Equipment (Clean Room Air Conditioning, Hygrometry, Pressure…), of fluids used in product manufacturing and control processes (water, air …) must be performed in accordance with Normative and Regulatory requirements. However, it is often hard to find one’s way through all the normative and regulatory documents and find out what is mandatory and what is indeed counter productive. This training course, which does not aim to teach you how to conceive one of these systems, will give you the necessary basis to write or verify a User Requirement Specification (URS) or a Qualification / Validation file concerning the main utilities of your company.

 Know how to control manufacturing environment (HVAC and Environmentally Controlled Area).

 Know how to control utilities in manufacturing and control processes (water, steam, compressed air, nitrogen…).

 Know European, American, and International Regulations applicable to main utilities. Know the key elements regarding utilities.

 Know the risks regarding utilities.

 Know how to define utilities specifications (URS) in regulatory context.

 Know how to qualify utilities.

1. Water and Steam

Design principles for Water and Steam production and distribution systems:
- Ion exchanger resin
- Reverse Osmosis
- Multi effects Distillers
- Thermo compression Distillers
- Clean and Pure Steam Generators
- Etc.…
Commissioning, Qualification and Validation of Water and Steam production and distribution systems:
- Specific Risks regarding water and steam systems
- Critical points not to forget in URS
- Specific Qualification tests for water and steam systems

2. Compressed Air and special Gas

Definitions concerning compressed air and special gas. Regulations and Standards regarding compressed air and special gas (Europe, USA and International). Design of gas production system:
- Compressed Air
- Nitrogen
- etc.
Commissioning, Qualification and Validation of Compressed Air production and distribution systems:
- Specific Risks regarding Compressed air production and distribution systems
- Critical points not to forget in URS
- Specific Qualification tests for Compressed air production and distribution systems
Commissioning, Qualification and Validation of Special Gas production and distribution systems:
- Specific Risks regarding Special Gas production and distribution systems
- Critical points not to forget in URS
- Specific Qualification tests for Special Gas production and distribution systems

3. Design of Environmentally controlled Area

Definitions concerning environmentally controlled Area. Regulations and Standards regarding environmentally controlled Area (Europe, USA and International).
Air conditioning principles:
- Temperature
- Hygrometry
- Pressure Differential
- Flow
- Particulates
Design principles for environmentally controlled Area: Critical points not to forget in URS. Qualification principles regarding environmentally controlled Area (test case typology, IQ, OQ, and PQ tests). Room mapping.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.