Issue 18, February 2006

A waste or rejection rate of 10%, unacceptable in most other industries, is considered good in the pharmaceutical industry. (according to Centre for Drug Evaluation and Research or CDER). Reject rates of 30% are not unknown for some production processes. Contamination is the main problem type.

Contamination control is a task that affects practically every area of pharmaceutical production. Parenterals often entail volatile drugs and high-risk routes of administration, so regardless of what filling method is used—from aseptic processing to barrier isolation to blow-fill-seal—pharmaceutical companies must be extremely alert for potential contamination.

As with most industries, it is important to identify the type, identity, source and extent of contamination in order to manage the risk associated with these areas appropriately. Without all this information, the right decisions cannot be made.

Identifying unknown contaminants is crucial to improving the bottom line for the industry. This often requires the skill of a research scientist/project manager. The internal training of production staff in the exploratory techniques to solve these problems is usually both time consuming and cost inefficient for what is generally considered a "one-off".

Contamination identification and characterisation require specialist knowledge and an understanding of the availability and limitations of current techniques. These techniques include:

• Advanced NMR programs (NOESY, APT COSY, HETCOR and PWGNMR)
• NIR, FTIR and Raman Spectroscopy
• Particle characterisation microscopy 
• SEM-EDX spectroscopy
• Mass spectrometry (accurate mass, ESI, IE, MALDI and APCI)
• GC/LC-MS

The ability to cross reference techniques, in order to assure that all the data withstands scrutiny, requires the individual to be trained and fluent in all techniques. In addition, contamination issues arising between sites and suppliers and contractors can result in litigation. Independent testing and unbiased opinion aids resolution.

Cetec offers a total solution package from initial consultancy, testing and investigation through to risk assessment and management. Our highly qualified consultants and NATA accredited laboratory are familiar with advances in modern analysis techniques, air and water quality, and risk management. Cetec also has an extensive network of contacts to University laboratories and CSIRO.

Next issue we will look at a typical process investigation in the pharmaceutical industry.

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