Colin Booth, Oxoid, UK
Arjan Langen, MSD, The Netherlands
Elaine Nichols, Oxoid, UK
- Acquire a Basic Knowledge in Microbiology
- Develop an Understanding for the Meaning of Microbiology for the Quality of Medicinal Products
- Get familiar with typical microbiological Tests in the Pharmaceutical Industry
- Learn to interpret microbiological Data correctly
It is the aim of this course to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.
The quality of drugs and the quality assurance during production are above all determined by their microbiological characteristics. The microbiological requirements on drugs are laid down in various regulations. When an authority inspects a company, it will focus its attention on these and on the requirements made on hygiene.
In their daily work, the responsible personnel in the production units has to understand microbiological results and evaluate their significance for further decisions. However, in practice many microbiological results are misinterpreted and thus often the wrong conclusions are drawn from them. When asked for the most frequent misinterpretations of microbiological results, pharmaceutical microbiologists gave the following answers.
The difference between bioburden and sterility testing (are they the same?)
The use of disinfectants guarantees the sterility of the object, surface, culture treated.
The distribution of microorganisms in a sample or on a surface is uniform.
Motile microorganisms can swim hundreds of meters in an hour causing contamination problems in remote parts of the facility.
How can different media formulations give different results?
Microbial tests described in the Pharmacopoeias can always be validated, no matter what the matrix is, how aggressive it is, e.g. NaOH, how high the concentrations of antibiotics are etc.
Identification results are absolute and unequivocal, especially when computer-generated.
Underestimating the importance of cleaning prior to disinfection.
Environmental monitoring results provide an accurate risk assessment during production.
How can clean room surfaces not be heavily contaminated when the air counts are out of specification?
How can endotoxins be present when the bioburden is nil?
How can the titre of a virus reference standard change according to the detection cell line used?
WFI is sterile.
Filters are absolute.
UV light disinfects and is capable of sterilising surfaces and water.
This listing appears to cover all aspects of microbiology from the interpretation of straightforward issues concerning environmental monitoring, bioburden results and identifications – through to the more complex issues surrounding virology results for the biologics/biotech people.
The misinterpretation of microbiological results often gives rise to the following misunderstandings:
Huge environmental monitoring programmes (more is better).
Rejection of batches due to minor out-of- specification results.
Delayed registration objectives and to attend appeal hearings.
Numerous contamination incidents due to the application of inappropriate solutions to problems.
Senseless promises made to regulatory authorities without scientific rationale based on the concept of quality.