GSK, Pall Speed Microbiological Contamination Detection

March 31, 2005
PAT Insider offers suppliers the opportunity to enlighten readers as to why a particular piece of equipment or software is a "must-have" for manufacturers implementing PAT.
Editors’ note: Believe in your PAT product? E-mail us with your top five reasons why firms should be taking notice. Here, Pall’s Peter Ball makes a case for Pallchek.Last year, Pall Corp.’s Pallchek Rapid Microbiology System was the first to be approved by FDA CBER for releasing pharmaceutical product manufactured by global supplier GlaxoSmithKline (GSK). It relies upon Pall’s Luminometer to detect microbiological contamination. There are several reasons such a system is attractive to pharmaceutical companies focused on both PAT and improving manufacturing efficiency.Pharmaceutical Manufacturing's PAT Insider gave Peter R. Ball, Pall Life Sciences’ director of new business development, a chance to elaborate on the benefits of Pallchek, and he gave us five reasons the system is worth checking into:
  1. Results can be obtained in 24 hours or less, compared with between five to seven to 14 days with current methods, says Ball. The Pallchek system detects a ubiquitous intracellular marker—adenosine triphosphate (ATP)—present in all living cells. In the majority of mainstream pharmaceutical products, ATP is present at very low levels. By using the appropriate, sensitive test procedures, detection of ATP provides rapid and compelling evidence of microbial contamination.

  2. The system is an extension of current pharmacopoeial methods accepted for many years, Ball adds. The current pharmacopoeial methods involve sample inoculation into broth, incubation and visual checking (usually over periods from five to 14 days) for the presence of turbidity, which demonstrates the presence of viable microorganisms. The Pallcheck system replaces turbidity with ATP detection.

    One of the current key recommendations from expert groups such as the United States Pharmacopoeia is that at least equivalence should be shown between new rapid methods and the current compendial method that they are replacing. Such comparability studies, as they are known, are facilitated with Pallchek, making regulatory acceptance simpler and less time-consuming.

  3. ROI is typically 12 to 18 months, Ball claims. The Pallchek Rapid Microbiology System is competitively priced, around one third or less than other comparable technologies, he says. Once technician time saving is included, the cost per test is typically lower than many of the methods that the product replaces.

  4. Pallchek does not require specialized laboratory facilities or extensive technician training, making implementation straightforward and economical.

  5. Ball’s last argument is that Pallchek is versatile, giving the user the opportunity to adopt the technology in a broad range of applications, including pharmaceutical product release, monitoring pharmaceutical water systems, environmental contamination monitoring, testing biological indicators used e.g. for autoclave validation and qualifying microbial suspensions used in critical tests (e.g. disinfectant potency testing, fertility testing of growth media).
Thus, adopting rapid microbiology does not have to be a lengthy, onerous or expensive process, Ball says, and the costs of validating and implementing new rapid technology can be recovered rapidly by selecting the appropriate technology.