solutions to air contamination ph star - m samy 2016

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Solutions to Air Contamination

Presented by: Pharma star for advanced technology

Eng Mohamed Samy cleanroom projects manager

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Solutions to Air Contamination

• Cleanroom Introduction • Turn key Cleanroom solutions• Cleanroom equipment• Abbreviations

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Solutions to Air Contamination

Cleanroom Introduction

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What is Cleanroom?

• It is clear that a cleanroom is a room that is clean !!!• A cleanroom now has a special meaning !!!• * Federal Standard 209 E• “A room in which the concentration of airborne particles

is controlled and which contains one or more clean zones”

• * ISO 14644-1• “A room in which the concentration of airborne particles

is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particle inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled and necessary”

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Standards and cleanliness

Federal Standard 209 E

* clean room systems is designed for the most stringent medical research and aseptic process applications under ISO Standards 14644 , U.S. Federal standard 209 E and European Union Guide to Good Manufacturing Practice .

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Standards and cleanliness ISO 14644-1 Standard

Comparison between selected equivalent classes of FS 209 and ISO 14644-1

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Standards and cleanliness European Union Guide to Good Manufacturing Practice

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Cleanroom Introductionclean room application :• Pharmaceutics industry

• Chemical industry• Active agent production• Genetic and biological

engineering• Laboratories• Pharmacies

• Medical technology• Optoelectronics• Microelectronics• Micromechanics

• Automotive industry• Nano-technology• Foodstuff industry

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Solutions to Air Contamination

Turn key Cleanroom solutions

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Turn key Cleanroom solutionsdesign and planning cleanroom

The successful Cleanroom starts with the design and planning process.

* Process flow* Personnel flow* Material flow* Process equipment & Layout

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Turn key Cleanroom solutions

Personnel flow

Gowning area

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Turn key Cleanroom solutions

Material flow

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Turn key Cleanroom solutions

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Turn key Cleanroom solutionsHVAC and Building Services

PH Star can supply a wide range of specialist HVAC and Building Services dedicated to the cleanroom class

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Turn key Cleanroom solutionsHVAC and Building Services

PH Star can supply a wide range of specialist HVAC and Building Services dedicated to the cleanroom class

Hvac ducts

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Turn key Cleanroom solutions

Clean room Panels

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Turn key Cleanroom solutionsElectrical works

Turn key Cleanroom solutions

S L DSHOP DRAWING

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Turn key Cleanroom solutionsClean room ceiling

simple or walk- on, with flush light fittings.

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Turn key Cleanroom solutionsClean room Flooring Epoxy / vinyl

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Turn key Cleanroom solutionsClean room Accessories

Differential Pressure gauge / Round corners / step over bench / air lock Circuit / Cleanroom furniture / Fir alarm and fir fitting / ……..

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Turn key Cleanroom solutionsClean room documentation

Validation and IQ / OQ• air balance • HEPA filter integrity test • Particle Count in each of the Clean Rooms as perUS Federal Standards 209E or Iso 14644 .• Checking and Setting Pressure gradient inside

the rooms• Speed test and uniformity of air flow test• Visualization flow test, smoke test• Temperature & Humidity inside the Rooms• Reporting all the above tests, with test

procedure reference

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Solutions to Air Contamination

Cleanroom equipment

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Cleanroom equipmentPH Star ceiling laminar air flow

Claf provides ultra clean sterile hepa filtered class 100 air in a isolated area where the highly sensitive process activities are carried out (filling & packing line etc )

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Cleanroom equipmentPH Star tower laminar air flow

The air is displaced from the ceiling to the ground with a parallel flow pattern and uniform output, which drags away all the polluting particles and expels them under the curtains to the outside (put on swivel casters ).

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Cleanroom equipmentPH Star vertical / horizontal

laminar air flow cabinet PH Star laminar air flow cabinet are designed for tissue culture, electronics inspection, medical device assembly and pharmacy drug preparation under ISO Class 5 (formerly Class 100) conditions to prevent airborne contaminations. We produce wide range of laminar air flow ( vertical – horizontal – biohazard ) laminar air flow .

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Cleanroom equipmentPH Star Weighing booth

Weighing booth protect operating personnel when weighing up and filling products containing active agents .Due to lower pressure in the working area, the possibility of cross contamination with other products is avoided.

Weighing booth• Weighing booth protect operating

personnel when weighing up and filling products containing active agents .

• Due to lower pressure in the working area, the possibility of cross contamination with other products is avoided.

Weighing booth

exhaust Hepa filter

Bag and pre filter

S.S 304 casing

plastic strip curtains

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Cleanroom equipmentPH Star Pass Box – Air shower

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Cleanroom equipmentPH Star Pass Box – Air shower

AVAILABLE OPTIONS• Alarm monitoring for air flow .• Magnehelic differential pressure

gauge for filter load indication .• High-quality ULPA "U15" down

flow filter with a typical efficiency of 99.9995% at 0.3 and 0.12 microns .

• Inner cabinet made off S.S 316

AVAILABLE OPTIONS• Qualification / Validation testing and

documentation to CGMP and ISO 14644-1 requirements :

• Preparation of protocols ( IQ , OQ )• HEPA filter integrity testing ( DOP test ) .• Airflow Particle Count analysis .• Differential Air Pressures (DP) .• Air speed .

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Solutions to Air Contamination

Abbreviations

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Turn key Cleanroom solutionsAbbreviations

• HEPA : High Efficiency Particulate Air• LAF : Laminar Air Flow• HVAC : Heating Ventilation Air Conditioning• AHU : Air Handling Unit • GMP : Good Manufacturing Practices • WHO : World Health Organization• IQ : Installation Qualification • OQ : Operational Qualification• PQ : Performance Qualification• FAT : Factory Acceptance Test• SAT : Site Acceptance Test• URS : User Requirement Specification• SOP : Standard Operating Procedure

Pharma Star for advanced technologyHead Office : 8 Hadaik Ramo – El Nasr Road Nasr City , Cairo – Egypt Tel. : (02) (4144350) (3 Lines)Fax : (02) (4177554)E-mail: pharmastar.eg@gmail.comFactory: El Obour city Tel. : 01002182137 / 0106 5510848