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Heating, Ventilation and AirConditioning (HVAC) Part 1 (a): Introduction and overview
WHO Technical Report Series, No. 937, 2006. Annex 2
Slide 1 of 26
To understand: The need for HVAC systems (Part 1a) The role of HVAC in protection:
– Personnel – Environment
The role of HVAC in dust control (Part 1b) HVAC system design and its components (Part 2) Commissioning, qualification and maintenance (Part 3)
HVAC | Slide 2 of 26 May 2006
relative humidity control where appropriate Supplement to basic GMP text 1.HVAC Introduction and Scope HVAC systems can have an impact on product quality It can provide comfortable conditions for operators The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage Temperature. 2 HVAC | Slide 3 of 26 May 2006 .
HVAC Factors contributing to quality products Personnel Validated processes Procedures Starting materials Equipment Packing materials Premises Environment HVAC | Slide 4 of 26 May 2006 .
3.HVAC The manufacturing environment is critical for product quality. Light Temperature Relative humidity Air movement Microbial contamination Particulate contamination Uncontrolled environment can lead to product degradation product contamination (including cross-contamination) loss of product and profit HVAC | Slide 5 of 26 May 2006 . Factors to be considered include: 1. 5. 4. 6. 2.
packaging or repackaging".HVAC What is contamination? It is "the undesired introduction of impurities (chemical/ microbial/ foreign matter into or on to starting material or intermediate – during sampling. particulate matter. endotoxins (degraded microorganisms). foreign products. Impurities could include products or substances other than the product manufactured. microorganisms. etc. Glossary HVAC | Slide 6 of 26 May 2006 . production.
Poorly designed. materials and equipment 3.g. Cross-contamination can result from.1. and movement of personnel. intermediate product.11 . Insufficiently cleaned equipment HVAC | Slide 7 of 26 May 2006 Glossary. operated or maintained air-handling systems and dust extraction systems 2. 1. Inadequate procedures for.HVAC What is Cross-contamination? "Contamination of a starting material. 4. e. or finished product with another starting material or product during production".
HVAC Cross-Contamination Contaminant from Environment Operators Contamination Contaminant from Equipment Product from Environment Operators HVAC | Slide 8 of 26 May 2006 Cross Contamination Product from Equipment .
Use of closed production systems 4.HVAC Cross-contamination can be minimized by. validated cleaning procedures 5. Correct air pressure cascade HVAC | Slide 9 of 26 May 2006 .g. Personnel procedures 2. Appropriate levels of protection of product 6. Adequate. e. Adequate premises 3. 1.
HVAC The guideline further focuses on three concepts of the system: Product protection – Contamination – Cross-contamination – Environmental conditions Personnel protection – Prevent contact – Comfort conditions Environment protection 2 HVAC | Slide 10 of 26 May 2006 .
1. should be classified as "clean areas" Achievement of clean area classification depends on factors such as: – Building finishes and structure – Air filtration – Air change rate – Room pressure – Temperature – Relative humidity – Material and personnel flow 4.4.HVAC Protection: Product and personnel Areas where materials and products are exposed.3 – Outside environment – Occupancy and type of product HVAC | Slide 11 of 26 May 2006 .1 .1.
1.4.6 Air change rate normally varies between 6 – 20 air changes per hour HVAC | Slide 12 of 26 May 2006 . – – – – – – – Level of protection required Quality and filtration of supply air Particulates generated Room configuration Containment effect Room heat load Room pressure 4.HVAC Air filtration and air change rate should ensure attainment of classification Air change rate is dependent on factors. e.1.4 .g.
7 .8 HVAC | Slide 13 of 26 May 2006 .4.1.HVAC The classification should be achieved in the state as specified (1): "As built" – Bare room.1. without equipment or personnel 4.
1. but no operators present 4.9 HVAC | Slide 14 of 26 May 2006 .HVAC The classification should be achieved in the state as specified (2): "At rest" – Equipment may be operating.
HVAC The classification should be achieved in the state as specified (3): "In operation" – Normal production process with equipment and personnel. – Clean up time validated – normally in the order of 20 minutes 4.10 HVAC | Slide 15 of 26 May 2006 .1.
4.12 . or displacement airflow Airborne particulates and level of filtration considered critical 4.HVAC Control of contaminants External contaminants removed through effective filtration Internal contaminants controlled through dilution and flushing.1.15 HVAC | Slide 16 of 26 May 2006 .1.
Class D Others Therapeutic risks HVAC | Slide 17 of 26 May 2006 Manufacturing Environment requirements .Cleanroom Class A / B Cleanroom Class C HVAC Cleanrm.
16 HVAC | Slide 18 of 26 May 2006 .HVAC Level of protection and air cleanliness determined according to: Product to be manufactured Process to be used Product susceptibility to degradation 4.1.
relative humidity HVAC | Slide 19 of 26 May 2006 . number of microorganisms in the air or on surfaces Number of air changes for each room Air velocity and airflow pattern Filters (type.HVAC Parameters influencing Levels of Protection Number of particles in the air. position) Air pressure differentials between rooms Temperature.
HVAC Tools to help achieve the desired Level of Protection Air Handling System Supply Air Production Room With Defined Requirements Outlet Air HVAC | Slide 20 of 26 May 2006 .
HVAC Tools to help achieve the desired Level of Protection (2) Air-handling system can be the main tool for reaching required parameters May not be sufficient as such Need for additional measures such as appropriate gowning (type of clothing. proper changing rooms) validated sanitation adequate transfer procedures for materials and personnel HVAC | Slide 21 of 26 May 2006 .
HVAC Tools to help achieve the desired Level of Protection (2) Cleanroom Class defined by Critical Parameters Air Handling System HVAC | Slide 22 of 26 May 2006 Additional Measures .
7 or 8 HVAC | Slide 23 of 26 May 2006 . EC.HVAC Examples of Levels of Protection Types of Clean room classes WHO. 2 or 3 Class 5. C. D Critical and controlled Level 1. PIC/S: US FDA: ISPE: ISO: A. B. 6.
000 HVAC | Slide 24 of 26 US 209D nonmetric US 209E 1992 metric EC cGMP Annex I 1997 Germany VDI 2083 1990 0 UK BS 5295 1989 Japan ISO 14644JIS B 9920 1 1989 2 3 4 2 3 4 5 1 10 100 M1 M 1.HVAC Comparing International Cleanroom Classifications Particles / m3 0.5 M7 May 2006 1 2 A.5 10 35 100 353 1.000 10.000 1.000.000 353.5 M6 M 6.5 M5 M 5.300 100.000.000 3. B A= unidirectional B= turbulent 3 E or F 5 1.000 100.5 M2 M 2.000 35.530.5 M4 M 4.5µm 1 3.000 4 C D 5 6 G or H J K 6 7 8 6 7 8 .000 3.000 10.530 10.5 M3 M 3.
1.g. warehouse Level 1 General Level 2 Protected Level 3 Controlled Area where steps are taken to protect exposed material/product. e.g. e. dispensing Area with defined.HVAC Examples of levels of protection 4.16 Level Condition Example of area Area with normal housekeeping. monitored environmental conditions to prevent contamination and degradation HVAC | Slide 25 of 26 May 2006 . controlled.
Example: Cleanroom Class Washing of containers Preparation of solution for terminal sterilisation Preparation of solutions for aseptic filling Depyrogenisation of containers Filling for terminal sterilisation Filling for aseptic process etc. X X X X X X X A B C D X HVAC | Slide 26 of 26 May 2006 .HVAC All operations within a pharmaceutical facilility should be correlated to well-defined clean room classes. and can be included in a hygiene concept.
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