Services for the Life Sciences

Temperature Mapping

Autoclave Cycle Development

Autoclave cycle development is a process that allows autoclave users to determine which combinations of autoclave cycle parameters and loads will meet their process requirements. This process is a design study performed before validation studies occur and provides the necessary data to determine which cycles and loads will be validated.

Autoclave cycle development is best accomplished by following a cycle development protocol. The cycle development protocol is similar to a Performance Qualification Protocol except it does not typically have acceptance criteria associated with it. The Cycle Development Protocol describes the particular procedures, cycle parameters and loads to be tested. The Protocol also describes the data to be collected. The cycle development protocol provides a systematic means of collecting the data necessary to determine which cycle parameters and loads meet the process requirements and should subsequently be validated.

Biometrix works closely with our clients to develop high quality cycle development protocols. Our cycle development protocols include a customized approach and methodology, clearly defined procedures, cycle descriptions and load configurations. We offer fast turnaround of documentation and can often schedule projects with short lead times.

Our validation personnel are always available to answer questions and can provide the kind of guidance that will assure a highly compliant cycle development study.


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Validation Services

Validation Master Plan
Autoclave Cycle Development
Validation Staffing
Validation Protocol
   Installation Qualification
   Operational Qualification
   Performance Qualification
Specification Documents
   Design Specification
   Functional Specification
   User Requirement Specification
Usability Studies
AABB Consulting

Equipment Qualification & Validation Capabilities

Autoclave Validation
Depyrogenation Oven Qualification and Validation
Lyophilizer Validation
Automated Filling Machine Validation
Filling Machine Validation
Freeze Dryer Validation
Calibration Software Validation
Centrifuge Validation
Chromatography Box Validation
Cold Room Validation
Computer Systems Validation
Environmental Chamber Validation
Environmental Room Validation
Filling Machine Validation
Freezer Validation
Glass Washer Validation
Humidity Chamber Validation
Incubator Validation
Laboratory Monitoring System Validation
Mixer Validation
Oven Validation
PLC Validation
Refrigerator Validation
Shaker Validation
Software Validation
Stability Chamber Validation
Stir Plate Validation
Stirrer Validation
Warm Room Validation

  • Biometrix Corporation
  • 301 Edgewater Place, Suite 100
  • Wakefield, MA 01880
  • Tel: (978) 338-5263