The Validation & Compliance Services Group can develop Installation Qualification Protocols for each critical utility or piece of equipment. The protocol provides for a systematic method of checking the static attributes of the equipment before the equipment is used. The IQ will start with a description of the system. This description will describe what the system is intended to do, and all major components of the system. The system will be reviewed post-installation to verify the system is as specified in the user requirement, detail design specifications, engineering drawings, data sheets, and manuals. As part of the IQ all such documentation will be identified and referenced.
The Validation & Compliance Services Group can develop Operation Qualification Protocols to describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ, all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs are manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.
The protocols can also be used as a Dry Run prior to shipping the equipment. This will accomplish two important goals:
The Validation & Compliance Services Group can develop Factory Acceptance Test protocols to provide documented evidence that a piece of equipment, system, or integrated process has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to being delivered to the end user. The FAT document will complete a series of verifications to ensure that what was ordered has been supplied by verifying the original purchase order and all specifications (URS, FRS, DDS) outlined, prior to the manufacture of the equipment, have been respected and incorporated on the finished product.Request more info about this product
NJM Packaging’s validation support team is available to assist your in-house validation team with the development of comprehensive validation test protocols customized to your specific equipment, internal documentation format and functional requirements.
Our Line Integration specifications depend on the customers’ individual project needs. Contact NJM Packaging for more information.
Our various accumulation (buffer) tables come in a range of sizes and types, including both BiFlow and circular, to meet the specific needs of each application for maximizing line productivity.
Conveyors feature a raised bed design, stainless steel construction, and a 4 ½" Delrin table top chain. They are available in various lengths.
Stainless steel conduits house electrical power wires and pneumatic pipes with panel-mount female receptacles for each machine.
A range of available inspection systems automatically identifies and rejects defects from the packaging line to reduce re-work and assure final product quality meets specifications.
The Model TE-20 Tablet Elevator improves ergonomics for workers by allowing an operator to fill the tablet hopper at a comfortable height. The elevator then lifts a bucket to feed a tablet counter or blister machine.
This solid dose packaging Tablet Entrapment Free (TEF) equipment is designed for pharmaceutical and nutraceutical manufacturers and contract packers handling tablets, softgels and capsules.
The industry leading ZPI Enterprise Manufacturing Diagnostics suite provides accurate and comprehensive data collection and analytical tools that provide packaging, manufacturing and processing facilities with the tools required to increase availability, improve performance, reduce quality defects, increase outputs, decrease costs, and increase profit margins.