Qualification / Documentation

We consider documentation as important as the equipments, helping the users to qualify and validate their systems.

The qualification of equipment, systems, and processes is a key pharmaceutical plant component in terms of pharmaceutical product quality assurance. Katalyst Bio Engineering focuses a great deal of attention on this from the very beginning. With its years of experience in plant design, construction, and startup, Katalyst Bio Engineering offers its customers a wealth of know-how for all qualification tasks. Precisely tailored to client needs, Katalyst Bio Engineering prepares qualification plans (from master plans to partial qualification projects), takes charge of creating protocols according to client guidelines, performs GMP compliant factory acceptance tests (FATs) with its own measuring equipment, and establishes complete documentation systems for continuous, GMP compliant project and plant documentations. On the basis of previously developed or the client’s own standardized operations and logging procedures, Katalyst Bio Engineering provides efficient IQ, OQ, PQ implementation and support in strict compliance with standard qualification mechanisms.

We consider documentation as important as the equipments, helping the users to qualify and validate their systems. We have in-house standard operating procedures (SOP’s) developed which are strictly followed to ensure the fabrication takes place in a safe and compliant environment. To ensure the best quality materials are used for manufacturing tests and certifications are supplied providing systemic proof of compliance while building the system.
We provide all documentation support to enable the customers complete their validation dossiers. The entire documentation package consists of:

  • Design Qualification (DQ) - a documented review of system design for conformance to operational and regulatory expectations
  • Installation Qualification (IQ) - part of final qualification activity, it relates to the detailed design of a system and verifies the installation of equipment and instruments
  • Operational Qualification (OQ) - ensure that individual components, instruments, controls and the system as whole operate on-site as designed
    These documents includes:
    • Drawings pre-construction & as built
    • Piping drawings
    • General Arrangement Drawings
    • Equipment Layout Drawings
    • Weld Maps
    • Inspection reports
    • Calibration reports
    • Manufacturer's certificates
    • Functional Specifications
    • Operating Manuals
    • Major Component - Mechanical and Electrical

Factory and Site Acceptance Testing

Factory Acceptance Testing of systems at our dedicated testing facility, assist users to get acclimatized to the system before it reaches site also providing close to real conditions while testing.

  1. FACTORY ACCEPTANCE TEST (FAT):
    • Piping and Instrumentation Check
    • IO Test
    • Equipment Installation Check
    • Pressure Hold test
    • Spray Ball Coverage Test
    • Control Cabinet Check with the Wiring Drawing
    • Process Calibration /Temperature
    • Process Calibration/ Agitator RPM
    • Process Calibration / DO2
    • Process Calibration/ pH
    • Welding Documentation Check
    • Steam Sterilization Sequence Test
    • Documentation Check Calibration Certificates
    • Documentation Check

    Various utilities that may be required while conducting the FAT can be met with our present day infrastructures. Project specific testing demands can be analyzed together with our clients prior to signing of the contract.

  2. SITE ACCEPTANCE TEST (SAT):

    The SAT will be done at the site of Installation by Customer and supervised by KATALYST BIO ENGINEERING. The SAT will be a repetition of some of the tests conducted during FAT.

    All tests will be conducted using standard operating procedures and formats of Katalyst Bio Engineering. All the tests will be conducted with the appropriate test records, test reference etc.
    The Project Quality Plan, Test Protocols and Functional Specification for individual units will be provided by KATALYST BIO ENGINEERING and approved jointly with Customer.

Installation & Commissioning

KATALYST BIO ENGINEERING assists on the commissioning of the equipment. Equipment lifting and shifting will be done under supervision of KATALYST BIO ENGINEERING.

Commissioning tests will also be witnessed to support later qualification activities on Validatable equipment.

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