SUPPLEMENTARY GUIDELINES ON

GOOD MANUFACTURING PRACTICES FOR

HEATING, VENTILATION AND AIR
CONDITIONING (HVAC) SYSTEMS
Review of draft proposals June 2006
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Contents

¾ 1. Introduction
¾ 2. Glossary
¾ 3. Scope of document
¾ 4. Product protection
¾ 5. Personnel Protection
¾ 6. Protection of the Environment
¾ 7. Systems and Components
¾ 8. Commissioning, Validation and Maintenance

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 Background

¾This guidance is not yet published.

¾It is being finalised NOW for intended
publication in Nov/Dec 2006.

3. Scope of document

2
3. Scope of
document

4. Product Protection:
Airflow configuration

3
 4. Product Protection:
Levels of protection

¾ This based on ISPE’s OSD Baseline™ Guide.

¾ Based on degree of exposure of products to the
process environment. 7

4. Product
Protection:
Examples

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 4. Product protection:
Air filtration

4. Product
protection:
Air filtration

10

5
 4. Product protection:
Airflow patterns

11

4. Product protection:
Airlocks

The ∆p values are

indicative – they
aren’t a requirement 12

6
5.Personal Protection:
Weighing
Several aspects
of operator
protection are
discussed in the
document.

In particular,
dynamic systems
such as downflow
booths are
identified a
effective for
processes such as
dispensing 13

5.Personal Protection:
more technologies

14

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 6: Protecting the environment:

¾The draft document has some limited

comments on the protection of the
environment.
¾Techniques described include:
¾Exhaust air filtration.
¾Scrubbers
¾Dilution stacks (fume cupboards)

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