Hygiene Monitoring

Regulatory guidelines for the manufacturing of pharmaceutical products are to be found in many national directives and legislative texts (EU-GMP, USP, Ph. Eur. ISO, AMWHV, FDA etc.). Their implementation is an integral part in guaranteeing a hygienic production environment. Surfaces, the room air and people will all be tested. Experience of sampling and evaluation of the results from the point of view of risk management are factors in successfully fulfilling hygiene standards. Determination of the germ count must be carried out in a GMP accredited laboratory.

As a GMP-certified and FDA registered contract laboratory in Switzerland, we can offer you holistic consultation in the areas of microbiology and hygiene monitoring. We can help you in defining a hygiene concept, taking your own specifications into account.

Would you like to know where the Critical Control Points (CCP) as part of the HACCP concept are? Which surfaces should be sampled and do you require support in your sampling?

Reasons for hygiene monitoring

The top priority is the safety of both patients and staff. A hygienic production environment, particularly in sterile production, is a measure to guarantee the quality of the products. The legislature has passed binding regulations to achieve this. Monitoring of hygienic conditions is typically carried out for the surroundings, the staff and for the items that are produced. The data collected must fulfil the cGMP regulations.

Through “trending” these data enable the recognition of potential weak points in the hygiene concept. Exceeding the limit values or even contamination can often be averted in advance.

Regulation and standards

The guidelines and regulations to be used are dependent on the type and intended purpose of the product or on the premises. Depending on the country and the target market, additional distinctions are necessary here. Criteria can be found in the following texts:

• The EU Guidelines for Good Manufacturing Practice (Parts I + II)
• PIC/S Guidelines for Good Manufacturing Practice for pharmaceutical products
• USP <1116> and USP <1117>
• The German “Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)” (Drug and Active Ingredient Manufacturing Regulations)
• DIN / ISO Standards (e.g. ISO 14644 and 14698)

Evaluation and determination of the measures will be carried out as part of the risk management process.

Microbiological quality control of air

Generally, there are two principles available for determination:

• A defined amount of air is drawn into an air plenum and the particles contained therein are then spun onto an agar and remain caught there.
• Using settle plates, it is possible to define the number of colony building units settling upon a particular surface per unit of time.

Attention: For the majority of settle plates, a maximum exposure time is given.

Microbiological control of surfaces

Contact plates with nutrient media (agar) are used for the sampling of surfaces. To obtain representative and reproducible results, we recommend that a sampling device such as a contact counter is used. This is the only way to control the contact pressures and contact times exactly.

Why is bacteria identification important? 

Using bacteria identification, it is often possible to localise the source of the contamination e.g. hygiene monitoring. To identify a bacteria, sub-cultures will be formed to achieve the level of purity needed for clear identification. Categorisation can be performed using bio-chemical methods, an exact identification of the bacteria is then achieved using PCR sequence analysis.

Who should monitor hygiene?

Everyone who is responsible for the safety of the patients and personnel!

• Classic: Pharmaceutical companies
• Clinics and hospitals
• Doctors working surgically
• A recommendation: Voluntary control in doctor’s surgeries
• Pharmacies

The following things should be observed in hygiene monitoring

Is sampling being carried out at a suitable location?

Along with the sampling point, the time point of the sampling is also relevant.

Are the nutrient media suitable?

Nutrient media should be tested for their suitability. Freedom from bacteria and growth promotion must be proven.

Is the suitable equipment available?

To satisfy the GMP demands, it is essential to use qualified sampling devices and incubators. Compliance with temperatures and archiving of the data must be guaranteed. That means that a complete quality management system is necessary.

Have the staff been trained?

Alongside the infrastructure and equipment, trained personnel are a requirement to achieve reliable results.

Transportation:

When taking your own sample, care should be taken to ensure that the packaging and transportation are suitable. We recommend transportation conditions which enable prompt analysis and guarantee that the results will not be falsified as a result of external influences (e.g. temperature).

Reasons for outsourcing

Samples for microbiological testing are particularly susceptible to contamination. This danger can be minimised by outsourcing the testing to experts.

Particular advantages for small businesses and practices:

• Simple access to a great wealth of experience
• Cost controlling: No follow-up costs for equipment, obtaining qualifications or training courses

Particular advantages for large customers:

• Being free from routine work and the opportunity to focus on core tasks
• Capacity peaks can be overcome
• Independent results from an accredited contract laboratory

Our services in detail:

• Consultation on hygiene monitoring
• Microbiological tests
• On site hygiene monitoring for air, surfaces and water as part of OQ/PQ and during cleaning intervals.
• Instruction of your employees in taking samples
• Preparation of tested nutrient media
• Testing your nutrient media for freedom from germs and growth promotion
• Testing the effectiveness of disinfectants
• Evaluation of the monitoring findings
• Identification of any detected germs
• Additional services are according to the directory of services or upon request