Pharmalucence formally CIS-US Inc.
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Capabilities and Specifications
Aseptic Filling
Lyophilization




Aseptic Filling



 

Pharmalucence's new state-of-the-art commercial vial filling line features:

  • Full integration
  • Automated and isolated aseptic filling
  • Piston and Peristaltic pump technology
  • 100% fill check by weight on all vials
  • Low Oxygen filling for oxygen sensitive products
  • 2ml to 100 ml vial sizes

Pharmalucence’s 70,000 sq ft facility in Billerica MA is designed to meet world-wide compliance standards and to produce both aseptic and terminally sterilized (liquid and lyophilized) small volume parenteral products.  Pharmalucence currently manufactures its own line of diagnostic commercial products (non-radioactive radiopharmaceuticals) and is currently performing techincal transfer tasks to produce Sun injectable products in the near future. The Pharmalucence manufacturing and testing groups are supported by a comprehensive Quality Management System.

The manufacturing scale at our new Billerica site is up to 34,000 10cc vials per batch for lyophilized products and 14,000 10cc vials for terminally sterilized products. The filling line, manufactured by Bosch, is fully isolated. The IMA/Life lyophilizer includes an auto load/unload system. The line is designed to handle vial sizes from 2cc to 100cc and incorporates 100 % fill check by weight. The filler has the capability to dispense product solution by peristaltic or piston pumps.

The Pharmalucence Quality Control group maintains a full range of analytical test equipment and has extensive experience with the transfer and validation of methods. Pharmalucence services include access to a cGMP warehouse with refrigerated and freezer storage for incoming material, intermediates and/or drug product. Full ICH stability storage is also utilized.

Product classes currently manufactured in the facility are all non-potent, non-cytotoxic. All product manufacture is supported with specific cleaning validation.

Pharmalucence has extensive manufacturing expertise with small volume parenterals, including fill volumes ranging from 0.5 mL to 5 mL. All products undergo 100% visual inspection. Pharmalucence maintains a full complement of labeling and packaging operations.

 


29 Dunham Road, Billerica, MA 01821 | Telephone: 781-275-7120    © Pharmalucence Inc. All rights reserved.
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