Hygiene monitoring is an extremely important element in the pharmaceutical business. Effective hygiene monitoring helps reducing levels of contamination in finished products, leading to improved quality, fewer batch rejections, and lower level of product recall
Eurofins Pharma offer a hygiene monitoring program customized for each customer. The program is put together between the client and a team of professional chemists, microbiologists, and technicians. The program is evaluated continually and will allow the client to make sound decisions that can save time and money.
A typical monitoring program is a combination of measuring for microorganisms and particles. The methods used are air sampling, particle sampling, swabs, and contact plates. Eurofins Pharma uses ISO standard 14644 for particle measuring and ISO standard 14698 and NMKL no. 5 for measuring of microorganisms.
Hygiene monitoring samples can be tested by Eurofins Pharma according to a vast array of analytical methods. Examples are: bioburden test, endotoxin/LAL test, total viable count according to Ph. Eur on purified water, water for injection, and highly purified water and ID on microorganism The chemical laboratory normally analyse for total organic carbon, conductivity, heavy metals, and nitrates. However, other chemical analysis can be performed if desired.
The results produced will give the client an indication of the status of the production environment. The results are also valuable for trending allowing the client to be attentive on tendencies and fluctuations in the microbiological environment and thus make the correct decisions.
Training and education of your personell
Eurofins Pharma also offers seminars on hygiene for production personnel in the pharmaceutical business. The seminars can be held at Eurofins Pharma in Vallensbæk or at the clients company.
Eurofins Pharma is a flexible and competent collaborating partner. We can assist our clients with regular visits, unannounced visits or assistance / support if acute problems occurs.