Manufacturing Line Commissioning Package

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extraktLAB offers the highest quality commissioning and training package on the market. The commissioning phase of the facility and equipment under cGMP regulation involves the verification that operations and facilities are working according to the specified design. The activity supports qualification efforts of the customer and gives them methods to verify that the equipment is suitable for the intended purpose.

Operational qualification of equipment takes place in two separate phases. The first phase is Factory Acceptance Testing that is typically conducted in conjunction with the customer to ensure the equipment is operating according to the manufacturer’s standards. Site acceptance testing is a verification of the factory acceptance test and often takes place after the equipment has been installed and verifies that nothing has changed since the equipment was tested at the factory.

Phases of Operational Qualification

Phase 1: Factory Acceptance Testing

Conducted in conjunction with the customer & ensures the equipment is operating according to the manufacturer’s standards.

Phase 2: Site Acceptance Testing

Verification of the factory acceptance test & often takes place after equipment installation. Verifies nothing has changed since the equipment was tested at the factory.

Deliverables

  • Onsite Training
  • On SOP Usage with Operator Certification

Standard Operating Procedures

  • Operations of Equipment
  • Cleaning
  • Sampling
  • Maintenance
  • FAT (Operational Qualification)
  • SAT (Installation Qualification)

Get More Information on Our Services

If you are interested in pricing and technical specs for our services, download our free brochure below

Additional Notes

  • GMP Equipment Commissioning and Training shall not exceed three days and is for one piece of equipment. If the commissioning and training exceeds this time frame, there will be additional costs per day of training.
  • Additional training will be charged $2500 USD per day (Part #80-9614)
  • Commissioning & Training is available for extraktLAB equipment only.
  • The customer is responsible for preparing the site and all personnel in advance of training start

Get in touch with our team to request a quote, learn more about our training or get help with your business plan.

We are dedicated to providing you with the best advice, quality and service in the industry.

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