System Testing & Qualification
Ensuring peak system performance
System testing and qualification testing and services supplied by YMC Process Technologies (YPT) ensure peak system performance. Tests and / or documentation services are noted below for:
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
A note about our partner for PM contracts and serves – ATG – is also found below.
System Testing Flow Chart
Factory Acceptance Test (FAT)
Successful execution of the FAT, whether executed by the Customer or by YPT, indicates that the system is released for shipment. The FAT protocol and report are included with the system Turnover Package (TOP).Customers may purchase an FAT to be performed collaboratively by customer representatives and YPT at our Devens, MA facility. FAT includes both static (Verification Testing) and dynamic testing (Operational Testing) of the system or major system components (see the Test Matrix below).YPT provides a recommended FAT protocol that is based on the pre-FAT protocol. The pre-FAT testing is performed by YPT to ensure that the system is ready for the FAT. Customers may include additional tests during FAT. The standard FAT duration is up to 5 days per system (8-hour day). YPT provides support equipment (tanks, hoses, etc.), purified water (DI water), process engineering support and automation engineering support. Standard FAT is performed with DI water. If other chemicals are required, they can be provided after approval by YPT for compatibility with facility requirements for an additional cost.
Site Acceptance Test (SAT)
Customers may purchase an SAT that demonstrates the system is installed properly and meets the environmental requirements (power supply, water supply, air supply, waste accommodations, and environmental conditions). The SAT also shows that the system was not damaged during shipping by challenging aspects of the system tested during the FAT. The SAT protocol is a subset of the tests outlined above.YPT can provide on-site support for customer-executed SAT. A typical SAT duration is 2 – 3 days and can include basic system training. ATG (our contract service provider) can also provide support for SAT with coordination with the YPT FAT Manager.
Installation Qualification (IQ)
The IQ is a verification procedure confirming that the system has been delivered complete to design, installed according to manufacturer specifications, and all labeling of the system components are correct. This is a quality control document which, when complete, is submitted for review, approval, and archiving by the customer’s quality assurance group. This is the first document an investigator/auditor would review for a system.
Operational Qualification (OQ)
The OQ is a verification procedure with the intent to test the system’s performance against the manufacturer’s specifications. It will confirm that all components which comprise the system are able to perform to the specification set by the manufacturer. This includes all moving components, such as the valves and pumps, and all analytical components, such as the pressure, temperature, UV, pH and conductivity meters. The overall goal of the OQ is to confirm the system has the capabilities claimed by the manufacturer so that the customer can operate the system within those capabilities.
ATG (our contract service provider) provides IQ/OQ protocols and IQ/OQ execution services with coordination with YPT FAT Manager.
ATG – a partner with YPT to ensure fast, friendly and expert service
ATG provides repair, maintenance, and contract services for laboratory research and bioprocess instruments. The EcoPrime System services performed by ATG engineers range up to and can include all parts and documentation needed to ensure your success and provide the traceability you need. ATG can supply NIST traceability documentation, conformance documentation for each part and elastomer replaced, calibration reports that validate your unit meets manufacturers’ specifications and ensure that your instrument is working at peak efficiency.With long experience in GMP and cleanroom environments, YPT with our select partner Analytical Technologies Group* adds significant value to any post sale system on-site qualification and maintenance.
Call ATG: + 1 877 334 0886
* Analytical Technologies Group is our select services provider partner in North America. YMC regional centers in Europe and Asia provide direct services in those geographies. Contact us at firstname.lastname@example.org let us know if we can help.