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Agawam, MA
1-800-631-1680
www.microtestlabs.com
Microtest Labs Expands Fill and Finish Manufacturing Services for Clinical Trial
Material
AGAWAM, MASS. – May 11, 2010 – Microtest Laboratories has announced the expansion
of its fill and finish manufacturing service for all Phases of clinical trials. The company is a
leader in providing flexible, customizable aseptic processing and fill/finish services for all
pharmaceutical producers conducting Phase 1, 2, or 3 clinical trials.
Microtest provides the flexibility for all types of pharmaceutical and biopharmaceutical
manufacturing. Microtest will formulate per the approved batch record, which may include
mixing, agitation, heating/cooling, etc. Microtest can provide problem solving experience to
any of the specifics of a manufacturer’s process. Post formulation, Microtest’s analytical
capabilities allow for a full spectrum of available in-process tests to ensure that the drug
product is formulated to the strict specifications set by the manufacturer. Post in-process
testing, filtration occurs utilizing the manufacturer’s specified filtration system, redundant as
applicable. The product is filled into the designated vial type/size specified by the
manufacturer as well as stoppered and capped using the manufacturer defined container
closure system. Product is filled, capped and sealed under an ISO Class 5 environmental
area.
Post fill, the product undergoes full 100% manual visual inspection, which is quality-
controlled post-inspection by a qualified operator by performing an AQL inspection. Product
is labeled per approved labels and stored in Microtest’s fully validated material control
department at a multitude of storage conditions.
“As Microtest is a leader in testing of pharmaceutical drug products, we offer the full release
package on-site thereby ensuring the most expeditious release of the product,” Mello said.
“The specification documents allow for maximum efficiency when the samples are taken and
released to our QC laboratories – both QC Microbiology and QC Analytical. Our
representatives can discuss the testing on any final drug product specification and
determine the most efficient release strategy.”
Microtest fill/finish operations comply with both U.S. FDA and European EMEA guidelines.
Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for
both the manufacture and release testing of final drug product.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device,
pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the
company’s expertise and flexible processes enhance product safety and security, accelerate
time to market, and minimize supply chain disruption. For more information, visit
http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
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