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Alcami, a leading
provider of custom development and manufacturing services for the
pharmaceutical and biotechnology industries, today announces strengthened
capabilities in analytical services at its Edison, New Jersey site.
Alcami's laboratories in Edison offer comprehensive chemistry,
environmental and microbial capabilities to support the development,
manufacture and release of medicines and consumer products. The Edison
site is the only contract testing operation in the state of New Jersey
capable of meeting FDA requirements for Antibiotic Analysis both using
USP < 81 > and helping clients develop, validate, and perform bridging
analysis to an alternative method per USP < 1223.1 >. The company has
also added 2,000 cubic feet of stability chamber space across the
network, new control systems for all chambers, and a state of the art
REES environmental monitoring system to maintain the safety and integrity
of its clients' stability samples at all times, with 770 cubic feet of
space in Edison.
Furthermore, the Edison team has a broad range of expertise in
multi-compendial testing and customized analysis, such as:
-- Antibiotic Analysis
-- Disinfectant Efficacy Testing
-- Cleaning Validations
-- API and Excipient Testing
-- Finished Product Release Testing
-- Water Testing
-- Microbial Assays
-- Packaging Component Testing
-- Sterility Testing
-- Method Validation and Optimization
-- Medical Device Testing
Beyond facility upgrades, Alcami continues to invest in people,
equipment, and processes. In 2016, approximately $500,000 has been
invested in upgrades in Edison. An increasing number of clients are
benefiting from Alcami's Saturday sample delivery program across all of
its laboratory locations which conserves precious time in receiving
samples without adding risks. Additionally, Alcami is transforming its
laboratories to drive industry leading operational performance based on
Lean principles. The company will complete this process in 2017.
The Edison, NJ site successfully completed a FDA General Inspection in
September 2016. The company is committed to its customers and to the
highest quality and regulatory compliance.
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