Compressed Air in Pharmaceutical Industry

SWISS GERMAN UNIVERSITY

GMP – Comp Compressed ressed Air in Pharmaceut Pharmaceutical ical Industry Industry

Compressed Air in Pharmaceutical Industry Paulus Gunawan [email protected]

9-Jan-13

Paulus Gunawan

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Source of contaminations • Inta Intake ke ai airr fro from m sur surro round undin ings gs (oil, dirt/dust and moisture/ water vapour, virus, bacteria, germ, micro-organisms) • Co Com mpressor un unit (note : equipment uses oil for lubricants) (including Air Receiver + Filters)

• Piping Piping Dis Distri tributi bution on Sys System temss and Fit Fittin tings/ gs/ Accessories (rust/particles)  ?

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Recommended Type Oil Free Compressed Air : Air compressed from initial pressure to final pressure using compressor in which the air is not in direct contact with any fluid or lubricant Achieved by using Oil Free Rotary Screw and Centrifugal Compressors

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Up-date Air Quality Classes • ISO 85 857 73. 3.1 1 Cl Claass 0 • Note : cont contam amina inatio tion n cannot cannot be elim elimina inated ted but can be reduced  starting from the source and by filtration – purification – equ ipment, separation through various equipment, media filter

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Parameters to be checked based on PIC Utility Inspection /

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Compressed Air in Pharmaceutical Facility • Opera Operati tion on of of Equi Equipm pmen entt (pneu (pneum mat atic ic system) Packing Equipment : Blister Pack Machine, Powder Filling Machine etc. • Va Vacu cuum um cl clea eani ning ng sy syst stem em • Spr Spray ay sys system tem (co (coati ating, ng, mixi ixing ng and FBD) • Others Others / Innov Innovati ation on : Table Tablett Press Press Mac Machin hine, e, Capsule Filling Machine, Drying Container 9-Jan-13

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Air Quality Testing • Du Durin ring g Per Perfor forma mance nce Qu Quali alific ficati ation on (PQ (PQ)) • Check Check an and d Test Testing ing aga agains instt ma majo jorr critica criticall parameters (key design criteria) 

Solid / Particle / Dust : Particle Counter Measuring Equipment  example Met One Particle Counter

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Liquid / Vapor / Moisture : PDP (pressure dew point)  hygrometer

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Oil content : Oil measuring kits from Drager Microba / Viable Organism testing (Slit to Agar) Air Sampler (Biotest diagnostic air sampler)

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FUNCTION Compressed Air in Pharmaceutical Production Use Compressed

Air Generation (Air Compressor) and Distribution Piping System should be suitable for production of dry and oil-free compressed air, continuous distribution of Compressed Compressed Air in sufficient quantity and quality to the points of o f use (POU)/ user point.

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COMPRESSED AIR QUALITY • The com compre presse ssed d air qual quality ity must com comply ply with the relevant ISO 8573-1 standard, quality class 1 for particles and oil residues (aerosol, liquid, and vapour), quality class 2 for humidity & liquid water (class 1.2.1) • Quality Quality req requir uirem ement entss should should be upda updated ted and revised if quality requirements are requested to higher standards. 9-Jan-13

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The Compressed Air Generation and Distribution/ Piping Systems Systems should be constructed according to GMP requirements.

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Dead legs/zones after sterile filters should be avoided.

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CONSTRUCTION REQUIREMENTS ß

Appropriate materials of manufacture must be selected and specified in accordance with GMP regulations depending on the specific application and process requirements.

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All materials, instruments and instrument enclosure materials shall be of durable durab le type.

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Compressed air contact parts should be made from FDA accepted materials (food grade standard)

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Surface finish on compressed air contact parts should be such that adherence of particle or liquids is minimized.

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Join materials, materials, then it should be crevice free and flush with the adjacent material.

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The surface finish shall be the same standard as the adjacent material.

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Non compressed air contact parts should be made of FDA accepted materi materials. als.

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The surface finish on non product contact parts should be such that cleaning of the surface made easy (easily cleaning)

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All pipes should be complete drainable and possible to sanitize

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CONSTRUCTION REQUIREMENTS • The The pipin piping g must must be be passi passivat vated ed in facto factory ry with with adequate passivation solutions and should be repassivation after completely installed • Compre Compresse ssed d Air Air Genera Generatio tion n and and Distrib Distributi ution on shal shalll operate in such a way that the th e compressed air produced flows smoothly through the pipe works to the point of use. • Stable Stable pre pressu ssure re com compr press essed ed air air at all all point point of of use (looped system preferable) 9-Jan-13

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CONSTRUCTION REQUIREMENTS CLEANABILITY and IDENTIFICATION • The out outer er sur surfa face ce of of Com Compr pres esse sed d Air Generation and Distribution Piping System should be easy to clean. • Identi Identific ficati ation on and flow dir direct ection ion shou should ld be available (marked)

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Parameters, Specification and Limits (URS) The Items could be slightly different depend of Users

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Other Parameters EHS Critical Parameters (Engineering Parameters Parame ters Not To Be Validated)

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Inspection on Compressed Air • Dr Draw awin ings gs an and d in inst stal alle led d (r (rea eali lity ty)) • Ma Maiint nten enan ance ce Pr Prog ogrram • Change Control

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“Check List In logical order “ √Contact with product or with process equipment √Typ Typee of of prod product uct – non ste steri rile le – ter term mina inally lly √Name tag/ labelling and identification of the system Connect ection ionss – ris risk k of mixmix-up up √Conn

√Identity all other used gases 9-Jan-13

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“Check List In logical order “ √Changing systems for filters √SIP systems / CIP √Back-up systems √Capacity vs. consumption √Maintenance program √Calibration program √SOP’s √Records √Breakdown / emergency including challenges o alarm systems 9-Jan-13

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Reference : • PIC/ PIC/S S PI 0909-3 3 Aide Aide Mem Memoi oire re Septe Septem mbe berr 2007 • Manu Manufac factu ture rerr Man Manua uall : Atla Atlass Copco Copco and and Ingersoll Rand • Pharm Pharmace aceuti utical cal Fac Facili ility ty Man Manage ageme ment, nt, JPS JPS Kohli

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Compressed Air in Pharmaceutical Industry

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