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June 8th-10th 2017, Bern - Switzerland

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Validations

Tema Sinergie is an ISO9001:2008 certified company since year 2000. According to ISO9001:2008 (Quality Management Systems – Requirements) all products undergo strict control check prior to equipment shipment to customer.

All tests are performed by high qualified internal personnel by means of calibrated instruments that satisfy all international standards.

Tema Sinergie hot cells are tested at the factory, before shipment, according to:

  • ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
  • ISO 10648-2 Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
  • ISO 14644-3 Cleanrooms and associated controlled environments - Part 3: Test methods
  • ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
  • ISO 10648-1 Containment enclosures - Part 1: Design principles
  • ISO 10648-2 Containment enclosures - Part 2: Classification according to leak tightness and associated checking methods
  • EEC – GMP
  • FS 209E standards
  • 21CFR pt.212

Tema Sinergie can supply an internal validation protocol FAT (Factory Acceptance Test) to be performed prior to equipment’s shipment to customer:

  • Scope and definition of protocol
  • Test instruments data and relevant calibration certificates
  • System documents list verification (materials and components datasheets, certificates, etc.)
  • “As built” drawings and schemes (construction design verification: ventilation, electrical, pneumatic, on site utilities, etc.)
  • Mechanical and interlocks test
  • Cell air-tight test (if applicable)
  • Filters integrity certification 
  • Unidirectional air velocity verification (for laminar air flow only)
  • Air flows visualization (smoke test)
  • Air changes per hour  
  • Air borne particulate cleanliness class test (“non-viable particle count”)
  • Glove test (if applicable)

On customer request Tema Sinergie can supply an internal validation protocol SAT (Site Acceptance Test) to be performed at customer site after the installation of the equipment,. The test includes:

  • Exterior finishing visual check
  • Main components visual check
  • Hot cell ventilation set-up
  • Mechanical and interlocks test
  • Main software functions check (on routine operation procedure)
  • Dispensing Systems working in hot conditions
  • Automatic Injectors working in hot conditions
  • Hot cell radiations interlocks check
  • Supply of all the documents and protocols of the tests performed at FAT

On customer request Tema Sinergie can supply an internal validation protocol I.Q.-O.Q. (Installation Qualification – Operational Qualification) to be performed at customer site after the installation of the equipment.

 

Moreover, on customer request agan, Tema Sinergie can supply the specialized personnel for assistance during PQ: the Performance Qualification represents the final qualification of the customer equipment/system. This includes a range of testing to simulate the production process options and provide assurance that the systems and the operating documentation are capable of subsequent process validation activities.

Tema Sinergie is an  ISPE associated and it is a member of ISPE ITALIA.