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 is specializing to provide the following services

EQUIPMENT & SETUPS SERVICES 

  • STEAM & SUPERHEATED WATER SPRAY AUTOCLAVES 

  • VIAL WASHING MACHINES

  • VISUAL INSPECTION MACHINES (KNAPP TEST)

  • DEPYROGENATION TUNNELS & OVENS

  • PACKAGING LINES

  • TOOLS WASHERS

  • CHAMBER,CONTROLLED CLIMATE UNITS

  • PREPARATION VESSELS 

  • PRE-FILLED SYRINGES MACHINES

  • VIALS FILLING MACHINES

  • BLOW FILL SEAL MACHINES (BFS)

  • FORM FILL SEAL  MACHINE (FFS)

  •  FUME HOODS, BIO SAFE CABINETS 

  • QUALIFICATION OF WATER SYSTEM

  • DISTRIBUTION LOOPS  WFI/PW 

  • HVAC AND AIR BALANCE

VALIDATION  & QUALITY SERVICES 

  • Validation Master Plans 

  • Site Master Plans 

  •  Computer system validation

  •  GxP critical Assessment 

  • 21 CFR part 11 Assessment 

  •  Contamination Control strategy (CCS) 

  •  Aseptic Control Strategy (ACS)

  •  Cleaning Validation (CV)

  •  Assessment for  Existing  HVAC Qualification

  •  Assessment for Existing Autoclave Qualification

  •  Autoclave Cycle development 

  •  Aseptic process Simulation (Media Fill) (APS)

  •  Attending and performing for FAT,SAT, IQ , OQ and PQ 

  •  Building of URS for Pharmaceutical lines 

  • Shipping Validation 

  • Quality Risk Management (QRM)

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Training 

Local and international trainers are available upon request to train you for the latest and best compliance : ​

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  • Sterilization validation 

  • Aseptic filling technique and guidance 

  • Lyophilization for beginners

  • Process Validation 

  • Cleaning Validation 

services: Services

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