Manufacturing Line Commissioning Package
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.
Phase 1: Factor 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.
Standard Operating Procedures
- Operations of Equipment
- Cleaning
- Sampling
- Maintenance
- FAT (Operational Qualification)
- SAT (Installation Qualification)
Deliverables
- Onsite Training
- On SOP Usage with Operator Certification
extraktLAB Services
Additional Notes
- GMP Equipment Commissioning and Training is for one piece of equipment and shall not exceed three days.
- If the commissioning and training exceeds included 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 PRIOR to training start date
Contact Us today
Our team has decades of experience in a variety of industries and is ready to provide advice tailored to your individual needs. Before any formal quotations are sent, we’d be more than happy to have a virtual meeting to discuss your project’s intent.
Step 1: Initial Consultation
Set up a call with us to discuss your project and determine if we’re a good fit for your needs.
Step 2: Discussion
We’ll explore multiple variations to identify the best approach for your product.
Step 3: Action Plan
Receive a detailed action plan, including suggested equipment and processes tailored to your specific application.
