Pharma Applications and Services

MGN International, Inc. offers a wide variety of products and services that support GMP (good measurement practices). GMP states that all equipment should be validated according to universal guidelines such as USP <788> which controls particulate matter in injections. MGN offers full validation servicing at the customer site, validation documentation such as DQ (design qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

MGN Offers a wide variety of easily validate able equipment designed to comply with specific universal guidelines. RION KL-04, for example is a fully automated All-In-One Particle Counting System designed for Pharmaceutical Injections (USP <788>). The KL-04 is the only particle counting system in the world offering a built in Pulse Height Analyzer which enables the user to manage all functions from calibration to performance test to internal noise check. This turnkey system is 21CFR Part 11 compliant with the built in computer. Easy and user friendly setup designated an administrator and unlimited users each with customizable privileges. It also offers Audit Trail Functions and allows for connection to networked or local printers. All necessary equipment (Sensor, sampler, computer) needed to operate the system is built in. KL-04 can be set to comply with USP, JP, EP, or BP regulations individually or simultaneously for companies who sell to many worldwide markets. KL-04 can also be used for other applications where <788> may not directly apply, but similar requirements would be useful.

MGN also offers Facility monitoring and Airborne Particle counting and other environmental sensors designed to meet new ISO regulations and verify differential pressure, temperature, relative humidity, gas detection sensors, and other parameters critical to any clean room environment and its’ compliance with ISO regulations. Models offer a variety of features such as data logging, 5 year battery or laser life for remote sensors, and full integration into current or upcoming facility monitoring systems.

All products offered by MGN International, Inc. can be calibrated and validated to meet any regulatory requirement. For more information on products or service offered by MGN, click on our Request Service or Request Quote links.