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Bacterial Identification

Gibraltar Laboratories helps its sponsors control microbial contamination in
the manufacturing environment. Raw material and finished products are
usually subject to a compendia and/or sponsor specification with respect to
what organisms, if any, can be present. Microbial identification is the
science of correctly identifying by name the organism[s] present. By knowing
what organisms are present it is possible to design control measures to
control them. These microbial control measures can then be verified for
effectiveness by monitoring [e.g. Bioburden testing, environmental air
sampling, cleaning validations, etc.] Clinically, precise bacterial
identification and pathogen detection is necessary for correct disease
diagnosis, treatment of infection and trace-back of disease outbreaks
associated with microbial infections. Bacterial identification is used in a
wide assortment of applications including microbial forensics, criminal
investigations, bio-terrorism threats and environmental studies. At
Gibraltar Laboratories microbial identification is based on assortment of
characteristics including, phenotypic, biochemical and genetic.

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Steam Sterilization

Steam sterilization is a process of thermal sterilization employing highly pressurized saturated steam in a chamber [autoclave]. Steam sterilization is a widely employed sterilization process. The basic principle of operation is that the air in the sterilizing chamber is displaced by the saturated steam, achieved by employing vents or traps in gravity-displacement cycles or by active removal in dynamic-air-removal cycles. In order to displace air more effectively from the chamber and from within articles, the sterilization cycle may include air and steam evacuation stages. The design or choice of a cycle for given products or components depends on a number of factors, including the heat lability of the material, knowledge of heat penetration into the articles, and other factors described under the validation program (see above). Apart from that description of steam sterilization cycle parameters, using a temperature of 121C, the F0 concept may be appropriate. The F0 , at a particular temperature other than 121C, is the time (in minutes) required to provide the lethality equivalent to that provided at 121C for a stated time. Medical instruments and their sterilization trays need to be validated both with respect to cleaning effectiveness and sterilization. Most commonly companies submit validation data performed in accordance with ST79. The key component of a persuasive validation is a thorough assessment of worst case conditions. Gibraltar Laboratories recommends that worse case be defined not only with respect to the article subject to the validation but also with respect to the steam sterilizer under maximal and minimal load configurations. This is necessary for each sterilization cycle type, namely gravity-displacement and dynamic-air-removal [pre-vacuum]. Accordingly one selects the instrument in the case that is judged to be the most difficult to sterilize. This instrument is then challenged with artificial soil and highly resistant biological spores. The tray is wrapped in accordance with ST79 and placed in the steam sterilizer at its cold spot. The cold spot is determined by thermal mapping with NIST traceable thermocouples. Three half-cycles are performed at 134C. In order to pass the validation all of the biological spores must be killed and the instrument or its tray must be completely dry.

A related and additional validation involves cleaning instruments that have been challenged. For example one can challenge with oils, protein, blood, endotoxin, particulates and cleaning agent. Cleaning is performed using one or both of a defined automated cleaning process or defined manual cleaning process. Successful cleaning is demonstrated by the removal of the challenge and absence of particulates and cleaning agent.

Daniel No Comments

Exciting Cancer and Molecular Biology Research at Gibraltar Laboratories

Research and Analysis

Gibraltar is busily involved with confidential cancer research, stem cell research and antiviral research.. An example of this category of research recently appeared in C&EN. As funding levels for cancer combating drugs reach an all-time high, scientists and researchers are turning to new, innovative techniques in their quest for medical breakthroughs. Gibraltar is at the cutting edge of offering the kinds of molecular services needed to advance breakthroughs in the treatment of difficult medical conditions.  For example, PI3Ks, formally known as phosphatidylinositol-3 kinases, are enzymes that are inherent in a vast amount of functions involved in facilitating a cell’s ability to perform properly. PI3Ks have become palpable targets for researchers developing cancer drugs.

The many intriguing aspects surrounding the correlation between tumors and PI3Ks have prompted numerous drug companies to ramp up research into the inhibition process. Biotech firms have even been established for the sole purpose of developing drugs which target the pathways that control normal cell growth and their subsequent role in sparking the development of cancer should they be defective. And while the promise for a major advance in battling cancer is possible, the process by which PI3Ks are properly utilized remains just as complicated as many had anticipated. Still companies remain optimistic that the compounds which block this signaling pathway will eventually be vital to cancer treatment. As such, the race to run clinical trials testing the effects of combining PI3K inhibitors with other drugs has greatly intensified.

Gibraltar Laboratories offers in vivo chemotherapy research,  advanced molecular techniques involving western blot analysis and stem cells to support efforts to test hypotheses. Ultimately, the researchers goal is a solution that knocks down cancer cells without being too toxic to normal cells. Fortunately researchers now have the benefit of understanding a molecular mechanisms and thus have gained insight into both the best drug combinations and which patients will most sufficiently respond. Gibraltar is proud to be part of this exciting race to cure and improve patient outcomes.

 

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New Publication Achievements

Dear Gibraltar Friend,

For many years we have set out to share knowledge through publication. All of our publications are listed on our website, https://www.gibraltarlabsinc.com/pubslist.html. Soon we will add two more to the list! “Common antiviral agents, structure, mechanism and spectrum of activity” will appear in CONTRACT PHARMA in the November/December 2010 issue.

The purpose of the paper is to review the status of antiviral drug development in the pharmaceutical industry. We present a compilation of current antiviral agents, a summary of major virus targets and a discussion of structure activity relationships.

In March of 2011 we expect our manuscript on “Relationship of subtype Influenza A pandemic strains to virucidal activity of a quaternary ammonium disinfectant” to appear in the Proceedings of Options VII. This is a follow up to our recent poster session presented at Options VII for the Control of Influenza Conference in Hong Kong, China, 3-7 September 2010. I will have more to share about that in the new year.

We are also proud of many of our early publications as some of them have become landmark papers for our industry. For example, “D-Values of Bacillus Pumilus Spores on Irradiated Devices (Inoculated Product)” Herbert N. Prince, Applied & Environmental Microbiology: p.392-393: February 1978 and “Bioburden Dynamics: The Viability of Microorganisms on Devices Before and After Sterilization” Herbert N Prince, Joseph R. Rubino, Medical Device & Diagnostic Industry, July 1984 are among the first published usages of the term “bioburden”.

We also like to read and one of my favorite new books is entitled, “Germs, Genes & Civilization: How Epidemics Shaped Who We Are Today” by David P. Clark. [You can find many of my favorite books at my LinkedIn profile]. http://www.linkedin.com/profile/edit?id=33408824&trk=hb_tab_pro_top. Clark shared this perspective about today’s human lifespan.

“…we live mostly long enough to worry about heart disease and cancer. But for most societies throughout history, most people met their end from infections caused by microorganisms of some kind.”

Thus, we are fortunate that through the work of our predecessors and the current work of respective companies that we have made great progress on many infectious diseases. However, now that we are living longer we must not compromise our bodies by neglecting exercise, not sleeping 7 to 8 hours per night and not having a healthy diet.

Sincerely yours,

Daniel Prince, Ph.D.

President

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Gibraltar Laboratories Inc. Wins ACIL SEAL OF EXCELLENCE HONORS

Award Certificates10-11-2010

I am proud to let you know that your laboratory has been publicly recognized as an excellent laboratory. Today Gibraltar was awarded two awards by the ACIL for the period 2010-2011.

1. SPECIAL RECOGNITION-TOP FIFTH TIMELINESS

2. SEAL OF EXCELLENCE – “For Demonstrated Ethics, Customer Service and Quality”

To win these prestigious awards Gibraltar competed against about 37 laboratories. By winning, Gibraltar demonstrated proof of annual ethics training and an early detection system for questionable analytical practices, submitted a signed code of ethics and distributed satisfaction surveys to our customers. Gibraltar scored very highly. Its customers rated Gibraltar a near perfect 3.83 out of 4.0 on Quality, Service, Expertise and Value!

I want to thank the Gibraltar team for achieving this great accomplishment!
Also, I thank all of our loyal customers that have helped us sustain and grow this laboratory for 40 years. This year we celebrated out 40th year of being in business. These awards are a hopeful sign that even more success is likely in the years ahead!

Lastly, if you are not yet a GBL customer why not become one now!

Award Certificates