SafeBridge Consultants Inc. Announces “Potent Compound Safety Certification” Approval of Almac Sciences, Craigavon, Northern Ireland, UK and Boehringer Ingelheim Chemicals, Petersburg, Virginia, USA

February 16, 2007

SafeBridge Consultants, Inc. (SafeBridge), headquartered in Mountain View, California, has announced that Almac Sciences (Almac) – a division of the Almac Group, Craigavon, Northern Ireland, UK and Boehringer Ingelheim Chemicals (BI Chemicals), Petersburg, Virginia, USA have met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and have been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients.

SafeBridge conducted a 60-element review of programs, procedures and containment of the active pharmaceutical ingredient synthesis areas at each site and based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that both Almac and BI Chemicals meet current industry standards for the safe handling of potent active pharmaceutical ingredients in certain areas of their plants dedicated to handling such materials.

For Almac, the programs and practices that exemplify this Certification included:

  • A focus on engineering controls for the containment of powder handling operations
  • Modern contained facilities in the GMP Labs for kilo scale operations
  • A comprehensive system of Standard Operating Procedures including potent compound safety elements

For BI Chemicals, the programs and practices that exemplify this Certification included:

  • The segregation of potent compound manufacture
  • The use of containment and control technologies in all powder handling operations (weighing and dispensing, drying, sampling, laboratory procedures, and product packaging)
  • Industrial hygiene monitoring surveys for assessing potential worker exposure
  • A comprehensive system of Standard Operating Procedures in potent compound safety

The SafeBridge® Potent Compound Safety Certification program verifies performance with set criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.

BI Chemicals and Almac become the third and fourth contract manufacturing organizations respectively to achieve Potent Compound Safety Certification by SafeBridge. Other companies previously achieving this Certification include Sigma Aldrich Fine Chemicals Inc. (SAFC), Madison, WI and Ferro Pfanstiehl Inc., Waukegan, IL.

SafeBridge Consultants, Inc. is the premier occupational health and safety consulting firm to the biotechnology, fine chemical and pharmaceutical industry with offices in Mountain View, CA, New York, NY and Liverpool, UK. SafeBridge has provided the Potent Compound Safety Triangle™ of services in industrial hygiene, occupational toxicology and industrial hygiene analytical chemistry to over 350 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.

For more information contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229
john.farris@safebridge.com

 

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