Wednesday, September 4, 2013

Regulations and Requirements for Pharmaceutical Microbiology Labs


In microbiology, quality assurance stands for the measures put in place to ensure quality control, as well as quality improvement. Quality control stands for the constant observation of work practices, paraphernalia and chemical substances so as to spot and correct defects. Once there are proper quality control measures in place, then quality improvement comes into focus as a way of making existing systems more efficient.


Importance of Microbiology Quality Assurance Procedures
Quality assurance in microbiology is imperative because it helps in trace-ability in case of contamination. Quality assurance involves strict observation and documentation of procedures. As such, if a microbiologist comes across contamination in a sample, he or she can go through the quality documentation and make corrections. In a situation where such documentation is unavailable, then it would be impossible to validate and act on sample test results. One of the consequences of sample invalidation is cost, as new samples would have to be collected and put through a lengthy testing phase.

Minimal Level of Pharmaceutical Microbiology Instruments Needed
Pharmaceutical microbiology is an aspect of industrial microbiology in charge for guaranteeing that medicines do not have dangerous levels of microorganisms. Like every other industry, pharmaceutical microbiology has its own industry-specific instruments. Below are some of the basic instruments, which are required in the field of pharmaceutical microbiology:

·         Incubator
·         Brittany
·         Vaccine Bath
·         Thermal Cycler
·         Inoculation loop
·         Petri dish
·         Mclntosh and Fildes anaerobic jar
·         Gas-pak
·         Vacuum pump
·         Durham’s tube
·         Bijou bottle
·         Blood collection bottle
·         Castaneda’s medium 
·         Universal container
·         Flat medical bottle
·         Tuberculin syringe
·         Desiccator
·         Pre-sterilized disposable container
·         VDRL rotator
·         Serological test slides
·         Lovibond comparator
·         Microtitle plates
·         Haemagglutination plate
·         Latex agglutination tiles
·         Cragie tube
·         Tissue culture bottles
·         Candle jar

Basic Standards in Pharmaceutical Microbiology
According to the World Health Organization technical report number 961.2011, there are a number of basic conditions expected in a pharmaceutical microbiology laboratory. To start with, we look at the human aspect of laboratory testing. The World Health Organization dictates that microbiology testing should be carried out and overseen by an experienced person in the field of microbiology. Moreover, support staff should have hands-on experience in microbiology, or a microbiology related field. This serves to ensure that testing processes are carried out properly for reliable results, which are used in the medical world.

The World Health Organization report 961.2011 also specifies the basic conditions for a microbiology laboratory premises. It states that equipment in a microbiology laboratory should be dedicated, and separate and from other equipment. In addition, microbiology laboratories should be designed in such a manner that they suit the operations they are to handle. For instance, a microbiology laboratory should have enough space to safeguard against mix-up and adulteration in the testing phase. 

Last but not least, the World Health Organization requires that sterility testing should be carried out as a basic testing prerequisite. It also lays down the conditions under which sterility testing should be carried out. For instance, sterility testing should be conducted in a Grade A unidirectional airflow sheltered zone or a bio-safety cupboard. This should be done in a clean room with a Grade B background.  

Learn more about microbiology quality assurance and pharmaceutical microbiology by contacting Biolumix.

Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830