Ensuring the Microbiological Quality of Clean Rooms

Products for environmental monitoring of areas used for the manufacture of sterile pharmaceutical products

It is a legal obligation for parenteral drugs and ophthalmic products to be sterile to protect the health of patients. Many such products cannot be terminally sterilised, so they must be manufactured aseptically, in designated clean rooms.

Environmental monitoring is used in the pharmaceutical industry to assess levels of process control and to ensure that environmental control systems in such clean rooms are effective.

Depending on the classification of the clean area, suitable, locally defined ALERT and ACTION levels for microbial loading must be established. The levels should reflect the capability of the clean room environment being monitored. Results approaching an alert level warn of a diminished level of control, allowing the situation to be rectified before the product is put at risk. Once an action level has been exceeded, a thorough investigation must be initiated and corrective actions taken.
In addition to indicating loss of environmental control, the data generated by monitoring can be used to highlight trends and changes in established microbiological patterns, thus allowing potential problem areas to be monitored closely and new problems to be anticipated.

The methods used in environmental monitoring include air sampling (both active, using automated air samplers, and passive, using settle plates), surface sampling (using contact plates or swabs) and personnel monitoring.

Thermo Scientific has developed a wide range of high quality, prepared culture media products, which are ideal for environmental monitoring in the pharmaceutical industry. These include 90mm settle plates (also available in ‘deep fill’ format to avoid desiccation of the medium), 140mm plates for use in air samplers and contact plates. These contain Tryptone Soya Agar, a general purpose medium, or Sabouraud Dextrose Agar, ideal for the growth of yeasts and moulds, available as standard, with or without neutralisers.

The plates are irradiated, and come triple-wrapped in transparent, permeable packaging, which helps to maintain the products in the optimum condition for use. Plates are also available in a VHP impermeable wrap, for protecting against Vapour-phase Hydrogen Peroxide sterilisation commonly used in Isolators and clean rooms.

Thermo Scientific Prepared Media products come with all the assurances of a well-established and reputable company. All products undergo quantitative quality control testing, using a low-dose inoculum to ensure optimum performance. Product specifications can be provided for all products. Certificates of origin for animal components are available with each batch, as are quantitative certificates of analysis.