NJM offers complete FDA or GAMP5 validation and compliance assistance to customers for an individual machine or an entire line. The qualification services offered include:
Working with experienced validation professionals, NJM uses an efficient, systematic approach to documentation in order to prepare qualification protocols while the equipment is being designed and assembled. Protocols are submitted for review and approval prior to equipment delivery. NJM employs a very pragmatic approach to protocol execution in order to fulfill all regulatory documentation requirements quickly and efficiently thus enabling customers to begin using equipment for production in the shortest time possible.
On-site implementation services are also offered by NJM.
At NJM, our turnkey line integration service starts well before the purchase order – with our dedicated applications engineering and sales departments. An assessment of available floor space, user requirement specifications, and packaging components allows our team to provide custom layouts that incorporate ProMach manufactured machines, third-party machines and even existing machinery – for innovative cost-effective solutions. From only a few containers per minute to speeds of 400 units per minute, the integration of both low and high speed filling equipment has been an NJM specialty for well over three decades.
By integrating an NJM raised-bed conveyor with a third party metal detector head, NJM has eliminated the need for bottle transfers. At speeds up to 250 units per minute, the CMD delivers superior performance and tablet entrapment free design to help manufacturers and contract packers ensure product safety and avoid costly product recalls.
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. NJM stand-alone inspection systems include fallen/upside down bottle, product, cotton, cap, and label inspections.
Standard Conveyors feature a sanitary raised bed design, stainless steel construction, and a 4.50 inch (114 mm) Delrin table top chain with AC motor and drive. They are available in various lengths to suit your current or future layout design requirements through its modular design.
The Tablet Entrapment Free (TEF) conveyors are designed for pharmaceutical and nutraceutical manufacturers, as well as contract packers. Its design meets strict cGMP guidelines. NJM has designed this conveyor for ease of inspection of trapped products. Thanks to the innovative quick tablet top chain release and integrated LED lighting.
NJM accumulation (buffer) tables come in a range of sizes and types, including both round and rectangular biflow, to meet the specific needs of each application for maximizing line productivity. They help create a buffer zone prior to the retorquing station to cool the induction sealed caps. They also allow the operator to change label rolls on the labeler without stopping the line.
The stainless conduits incorporate the power and controls electrical wires and flexible pneumatic tubing that distribute power and compressed air to the individual machines as per their requirements. A strategically located central electrical enclosure, combined with the line conduits, enables a single power and air service drop for efficient utility distribution to the entire packaging line. This entire solution results in a cGMP clean design for your line.
ZPI, a ProMach brand, develops and supports software based systems focused on enhancing the performance of packaged goods manufacturing processes. These include software solutions for packaging line OEE monitoring and data collection, serialization and tracking, and predictive maintenance.