Following a documented methodology
Commissioning in the pharmaceutical manufacturing industry is a documented methodology followed by PharmaMatrix, LLC’s qualified teams to guarantee that the facilities, systems and equipment used comply with the beliefs of all stakeholders. During this process, our pharmaceutical commissioning services verify that the equipment and programs installed are as specified, are functioning correctly, and operation has been handed off to the end user.
Factory Acceptance Testing (FAT)
PharmaMatrix conducts equipment factory acceptance tests to identify potential issues and remediate them before shipment, with the aim of being able to install and operate smoothly and quickly after installation. These may be performed on the equipment supplier’s premises before delivery and installation to the site, or after the equipment has been delivered.
The FAT tests typically comprise a range of different inspection points, conformity checks and verifications, including determining whether the equipment matches the original specification data. Tests are performed at various levels, ranging from a basic level that involves setting up the main components using temporary connections, to an advanced level that requires the complete installation of the equipment for testing purposes. This is then followed by breaking down the equipment for transportation and reinstallation at the customer’s premises.
FAT testing includes:
- a review of the original agreement to ensure contractual obligations have been met,
- verification that the equipment is fabricated according to the drawings and specifications, and that the manufacturing quality is acceptable
- verification of relevant documents, such as user manuals and instructions
- review of the applicable standards and specifications, and all safety guidelines available
- review and verification of the information on the equipment nameplate
- review and verification of the motor data, model and serial number, and confirmation that the motor classification meets the specified standards
- pressure testing of all lines to ensure acceptable performance
- system vacuum testing to ensure the equipment meets acceptance criteria
- a water test procedure that simulates the system in operation to provide proof of functionality
- agitator rotation and pump tests, to verify all components are operating as expected, and
- a documentation review to verify that all documentation is complete.
After testing a punch list is compiled of modifications or adjustments required before delivery.
With our vast experience on both the client and the consultancy sides, PharmaMatrix delivers pharmaceutical commissioning services accompanied by a clear and detailed understanding of the challenges involved in the start-up of a new process and in seeing it through to fruition.
Inspection is the process by which PharmaMatrix verifies the construction and installation adheres to the design, specified construction standards and materials, as well as legal or regulatory requirements. Inspection can begin before or after a system is declared Physically Complete, depending on the nature of the system.
Much of the inspection process is visual and it includes verification of drawings, structural integrity testing, reviews of material certifications and code certifications, and loop checks. Certain components require operational testing, however, which includes:
- Smoke/DOP tests
- Electrical voltage, resistance, and continuity tests
- Hydrostatic tests
- Pneumatic tests
- Flow and drain tests
- Pump and agitator rotation tests
Inspection is completed once the equipment arrives at the customer site and is installed at its intended location. This activity verifies that all components of the equipment are received and are installed as required prior to testing at the site (SAT).
Site Acceptance Testing (SAT)
This testing is performed at the customer’s site, using actual utilities such as electricity, water, and air supplies. Its main purpose is to verify the equipment performs the intended functions after shipment and installation at the final location. This testing also verifies any modifications that were completed as a result of FAT.
- reviewing the original documentation, verifying that the equipment conforms to specifications and that manufacturing quality is as expected.
- functional testing of the performance of all equipment items, including water test procedures, simulation and pressure testing, using actual utilities at the site.
- Verification of the FAT punch list to ensure all requirements have been carried out.
Our qualified team at PharmaMatrix can provide technical support staff to augment your internal team to author and execute IQ, OQ and PQ documentation to meet and exceed the requirements of an audit. Documentation can also include calibration and preventative maintenance SOPs.
In addition, our pharmaceutical commissioning services will assist and prepare your Quality Department for both internal and external audits, by either your client or a Federal agency. If required, we will also perform document and data reviews, conduct internal process audits to detect and correct non-compliance, assist with audit responses in respect of 21 CFR Part 11 compliance, and author SOP documents.
Leveraging Expertise on Your Behalf
Our goal at all times is to leverage our knowledge and expertise to enable your pharmaceutical manufacturing organization to speed up the development of pharmaceutical products, gain efficiencies, avoid operational disruption, and maximize your uptime and productivity.
With a client base that ranges in both size and scale, PharmaMatrix deploys customized solutions for every pharmaceutical manufacturing company we serve, supporting our customers through every phase of your product’s life-cycle.
We meet with our clients on-site to ensure we fully understand your requirements, and we aim to advance the growth of your business through effective process execution.
Whether your company is involved in a capacity expansion project, new product development, or change control for a new division, PharmaMatrix, LLC, can provide you with the pharmaceutical commissioning services you require. Our experience in managing high-value biotech and pharmaceutical projects puts us at the forefront of service organizations engaged in this industry.
Using quality commissioning and validation services results in an abundance of opportunity for your company while our faith-based operating principles offer the assurance that we work in your best interest at all times.
Contact us today to discuss your pharmaceutical commissioning requirements and discover how your firm can enjoy the reassurance of knowing your project will start on time and on budget.
*All engineering services, including automation and controls, instrumentation design, and commissioning and validation, are provided by associated entity KWW Engineering, PLLC (P-1686).