Berkshire Sterile Manufacturing (BSM), a sterile filling contract manufacturer located in Lee, MA, recently expanded its laboratory capabilities through purchasing new and improved equipment for container closure integrity testing (CCIT), product identification testing, and neat testing, among others. These purchases are in line with the company’s continued growth to offer expanded and improved analytical testing capabilities to support their clients’ drug product manufacture.
BSM has added container closure integrity testing (CCIT) via vacuum decay as an additional capability. This technology is highly regarded as the best method to accurately assess container integrity for multiple product types. It greatly reduces or eliminates events that can cause uncertainty over other methods of CCIT testing such as dye ingress and high voltage leak detection. The method is also nondestructive, allowing the lab to use analyzed units for additional analytical testing and increase the overall drug product yield for the client. This is particularly valuable for clients with limited or expensive clinical material.
In addition to expanded CCIT testing, BSM acquired a SoloVPE analyzer for neat testing of concentrated proteins, a micro plate reader for faster processing of clean room plates, a TruScan RM analyzer which is used to analyze the ID of products through their containers, and a LIMS system to manage lot testing, stability, and environmental monitoring.
BSM’s purchase of TruScan utilizes Raman infrared to analyze materials through their container. This is advantageous for analyzing multiple bottles of drug substance (DS). Identification testing results for all containers can be collected in a matter of seconds without breaking the receptacles’ seals.
These technologies will expand BSM’s current cGMP testing capabilities. BSM is also capable of providing analytical support through UPLC/HPLC systems, nanodrop and traditional UV spectrophotometers, pH, osmolality, SDS page, ELIZA, FTIR, bioburden, and endotoxin. This growth will help BSM address its clients’ analytical needs for in-process, release, and stability testing.
BSM Vice President of Quality Control, Devin Wigington, concluded, “We are consistently expanding to meet our customers’ needs, and we are thrilled to offer these enhanced capabilities to support their drug production.”