Post on 14-Jan-2017
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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