Air Handling Systems

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Power point presentation on Air Handling Unit

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Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal Manager – GMP Dey’s Medical Stores (Mfg) Ltd Kolkata

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Air conditioning System Dust Control System Extract ventilation Unitary Equipment : Reverse flow booth for powder dispensing Laminar Flow Benches Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Objectives To understand: The need and reason for pharmaceutical air handling systems The technical requirements for air handling systems Different types of air handling systems Qualification and monitoring requirements Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Factors that contribute to quality products: Raw and packaging materials Validated processes Personnel Procedures Equipment Design and quality of premises Manufacturing environment Inadequacies in the above factors will lead to sub-standard products Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems The manufacturing environment is critical for product quality Light Temperature Humidity Air movement Microbial contamination Particulate contamination Uncontrolled environment can lead to product degradation product contamination and loss of product and profit Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems What are contaminants ? Contaminants are Foreign products Particulate matter Micro-organisms Endotoxins (degraded micro-organisms) Cross-contamination is a particular case of contamination Contamination of a starting material, intermediate product, or finished product with another starting material or product during production. (WHO) Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems What are contaminants? Contaminants can originate from: Environment (particles, micro-organisms, dust containing other products). Equipment (residues of other products, oil, particles, rust, gaskets, metal) and can be brought into the product by air movements. Contaminants are in fact the presence of anything in the manufactured product which should not be there. Contaminants can be: Products or substances other than the product manufactured (e.g. products resulting from air pollution). Foreign products, such as metal parts from equipment, paint chips, etc. Particulate matter, especially dangerous in injectables. Micro-organisms – a particular problem for sterile products. Endotoxins: Even if killed by thermal treatment, micro-organisms are degraded to endo toxins and can cause damage Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Cross-Contamination From where does Cross-Contamination originate? Poorly designed air handling systems and dust extraction systems Poorly operated and maintained air handling systems and dust extraction systems Inadequate procedures for personnel and equipment Insufficiently cleaned equipment Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Cross-Contamination Cross-contamination can be minimized by: Personnel procedures Adequate premises Use of closed production systems Adequate, validated cleaning procedures Appropriate levels of protection of product Correct air pressure cascade Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Level of Protection Concept Defines environmental requirements, helps prevent contamination and cross-contamination Allows production under optimal hygiene conditions Takes into account product sensitivity to contamination therapeutic risk Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Levels of Protection Parameters to be defined: Air cleanliness requirements (filters type and position, air changes, air flow patterns, pressure differentials, contamination levels by particulate matter and micro-organisms) Personnel and material transfer methods Permitted operations Building design and finishes Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Levels of Protection Types of Clean room Classes International WHO - A, B, C, D EC, PIC/S, TGA, etc. : A, B, C, D US FDA : critical and controlled ISPE: level 1, 2 or 3 or clean room class National Companies : various others Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Levels of Protection All operations within a pharmaceutical facility must be correlated to well-defined clean room classes, and can be included in a hygiene concept. Clean room Class A B C D Washing of Container √ Prepn. of soln. for Terminal sterilisation √ Prepn. For aseptic filling √ √ √ Depyrogenation of container √ Filling for terminal sterilisation √ Aseptic filling √ Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Levels of Protection Based on the clean room class requirements, various Levels of Protection have to be created, including: Correlation between process operations and clean room classes Type of operation permitted in each Level of Protection Definition of clean room class (parameters, building materials, room requirements, HVAC systems) Requirements for personnel and material in the different classes (clothing, training, type of materials, etc.) Requirements on entry conditions for personnel and material (change procedures ) Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Parameters influencing Levels of Protection Number of particles in the air Number of micro-organisms in the air or on surfaces Number of air changes for each room Air velocity Air flow pattern Filters ( type, position ) Air pressure differentials between rooms Temperature, humidity Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Parameters influencing Levels of Protection Air handling systems: Are the main tool for reaching required parameters, But are not 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 Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Particles/m 0.5 μ m US 209 D Particles/ft 0.5 μ m US 209 E 1992 Metric EC cGMP Annex 1 1997 Germany VDI 2083 1990 UK BS 5295 1989 Japan JIS B 9920 1989 I S O 14844 -1 1 3.5 0 2 2 10 M 1 35 1 M 1.5 1 3 3 100 M 2 353 10 M 2.5 2 4 4 1000 M 3 3530 100 M 3.5 A-L , B -T 3 E or F 5 5 10 000 M 4 35 300 1 000 M 4.5 B 4 G or H 6 6 100 000 M 5 353 000 10 000 M 5.5 C 5 J 7 7 1 000 000 M 6 3 530 000 100 000 M 6.5 D 6 K 8 8 10 000 000 M 7 Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Dp >10µm 10µm> Dp> 1µm Dp< 1µm Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Classification of filters according to their Classification Average Efficiency Integral Value Peak Arrestance Local Value Retention in % Penetration Efficiency Penetration F9 85 15 H11 95 0.05 H12 99.5 5x10ˉ 97.5 25x10ˉ H13 99.95 5x10ˉ 99.75 25x10ˉ U14 99.995 5x10ˉ 99.975 25x10ˉ Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems AHU Configuration Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Airflow diagram-Once Thru System Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Airflow diagram-Recirculation System Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems FLOOR MOUNTED AHU Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems AHU ON SERVICE FLOOR Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems CEILING SUSPENDED AHU Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Contaminants can originate from : Environment (particles, micro-organisms, dust containing other products). Equipment (residues of other products, oil, particles, rust, gaskets, metal) and can be brought into the product by air movements. Contaminants are in fact the presence of anything in the manufactured product which should not be there. Contaminants can be: Products or substances other than the product manufactured (e.g. products resulting from air pollution). Foreign products, such as metal parts from equipment, paint chips,etc. Particulate matter, especially dangerous in injectables. Micro-organisms – a particular problem for sterile products. Endotoxins: Even if killed by thermal treatment, micro-organisms are degraded to endotoxins and can cause damage Anup Pal

Air Handling Systems HVAC Systems:

Air Handling Systems HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Pressure cascade injectables, Protection from micro-organisms and particles Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Pressure cascade solids, Protection from cross-contamination Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Final filter position Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

Air Handling Systems (AHU) HVAC Systems:

Air Handling Systems (AHU) HVAC Systems Anup Pal

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