News | August 10, 2015

New Jersey Contract Research Organization Provides Thorough Environmental Monitoring

Gibraltar Laboratories, Inc. provides contract research as well as extensive sterilization services for clientele all throughout the United States. Through their roughly 40,000 square foot research laboratories in Fairfield and Pine Brook, New Jersey, they are able to deliver a variety of services to their clientele, which include the medical device, tissue bank, orthopedic, biopharmaceutical, chemical and cosmetic industries. Right now, Gibraltar Laboratories is advising clientele that they provide high-quality thorough environmental monitoring and testing services as well.

Environmental monitoring tests are a vital part of the operations of many industries. Proper environmental monitoring and testing helps ensure businesses that their working space is free of airborne micro-organisms that have the potential to reproduce on surfaces, and debris such as dust. Environmental monitoring can be performed in any area with a controlled environment, including cleanrooms and manufacturing areas.

According to an international standard designated ISO 14644, environmental testing and monitoring are indispensable for the aerospace, pharmaceutical, microelectronic, medical device, food and healthcare industries. Another standard known as USP <1116> requires that certain products be produced in environments that undergo regular environmental testing. These products include:

  • Sterile pharmaceutical products
  • Sterile intermediates
  • Excipients
  • Certain medical devices
  • Sterile bulk drugs and other substances

Gibraltar Laboratories manages a group of travelling microbiologists with extensive qualifications and equipment. When they arrive on-site, they thoroughly test every environment needed. This includes the personnel themselves as well as the air and surfaces around them. The microbiologists can also take samples of nitrogen, compressed air and water as needed. Environmental testers from Gibraltar verify that environments in compounding pharmacies meet the standards set by USP Chapter <797>.

In addition to providing environmental testing for cleanrooms, laboratories and more, staff from Gibraltar Laboratories, Inc. also help train their client's personnel in relation to their garbing, gloving and aseptic techniques.

Source: Gibraltar Laboratories, Inc.