While every YMC platform system passes a factory release test and is delivered with a complete document set and QA certification, YMC offers full Factory Acceptance Testing (FAT) performed by YMC or in conjunction with customer representatives at our Devens, MA, facility. Our testing consists of the following:
Standard customer-performed FAT duration is up to five days per system at eight hours per day. FATs for multiple systems are typically run concurrently.
YMC will provide the following during FAT testing:
Standard customer-performed FAT will utilize DI water; if other chemicals are required, they can be provided after approval by YMC for an additional cost.
System testing and qualification testing and services supplied by YMC ensure peak system performance. Tests and/or documentation services are noted below for:
Successful execution of the FAT, whether by the customer or by YMC, indicates that the system is released for shipment. The FAT protocol and report are included with the system Turnover Package (TOP). Customers may purchase a FAT to be performed collaboratively by customer representatives or by YMC 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). YMC provides a recommended FAT protocol based on the pre-FAT protocol. The pre-FAT testing is performed by YMC to ensure that the system is ready for the FAT. Customers may include additional tests during the FAT.
The standard FAT duration is up to five days per system (eight-hour days). 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 YMC for compatibility with facility requirements for an additional cost.
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. YMC can provide on-site support for a customer-executed SAT. A typical SAT duration is two to three days and can include basic system training.
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 that, when completed, 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.
The OQ is a verification procedure intended to test the system’s performance against the manufacturer’s specifications. It confirms that all components that 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.
Contichrom® CUBE 30/100 (FPLC) Contichrom® CUBE Combined 30/100 (FPLC) Contichrom® HPLC 30/100 Service Contracts
Preventive Maintenance Service
Factory Acceptance Test
YMC downstream process systems – custom or standard
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