Pharmaceutical Industry Classification

The handling of hazardous and toxic substances in the pharmaceutical, medical and agri-food sectors requires appropriate equipment to ensure that processes comply with standards and regulatory requirements. The use of an isolator is essential to protect the product, the operator and the environment. For effective protection, the class of the containment solution must be chosen appropriately. Here is the pharmaceutical industry classification.

How is the degree of danger classified?

Containment systems come in a variety of ‘classes’, to comply with the pharmaceutical industry's classification. To determine the right class for your processes, you need to consider the isolator's area of use and its application. The law imposes specific threshold values for each product. These values are essential in choosing the right systems and components, and also in selecting the work procedure to be used to ensure that substances are handled under optimum conditions.

Here are the threshold values or classifications set by the legislator:

The OEB value

The OEB (Occupation Exposure Band) is an approach that classifies chemical substances according to their harmful effects on health. They are classified with great precision ‘in categories’ or ‘bands’. The classification is based on the level of toxicity. If the product is highly toxic, it is de facto given a high classification.

The OEL value

The OEL value (Occupational Exposure Limit) or LEP value (Limite d'Exposition Professionnelle) refers to the weighted average concentration of a product in the air on site. It is measured over a set period of time. In this type of environment, employees run no risk as long as the toxicity of the substance does not exceed the set value. The PEL value is expressed in mg/m3, parts per million (ppm) or fibres/cc. It is used to protect exposed operators from occupational illness.

To ensure the safe handling of hazardous and toxic substances, you must not only rely on the pharmaceutical industry's classification. You also need to ensure that the process is closed and tight for better protection. To meet your process requirements, some manufacturers now offer high-performance isolators.

Why use an isolator for toxic processes if you want to comply with the pharmaceutical industry's classification?

Isolators for toxic processes are extremely useful in the pharmaceutical industry. It is used to protect the product from external particulate and microbiological elements. Thanks to its high-performance containment system, it also protects the operator and the environment. The level of safety it offers complies with the pharmaceutical industry classification laid down by standards and regulations.

When integrating isolators, attention must be paid to their characteristics to guarantee their performance. If they are to provide effective protection for the handling and packaging of highly active or hazardous substances, they need to be fitted with a hermetically sealed barrier system.

To keep the air in the enclosure clean, the isolator can also incorporate a laminar flow or turbulent flow air diffusion system. It combines both sterility and toxicity. It is also fitted with high-efficiency HEPA filters and a bio-decontamination system using hydrogen peroxide (H2O2). Finally, the conditions in the chamber can be regulated. You can control and record parameters relating to temperature, pressure, humidity, etc.

Who Should I Contact to Install an Isolator?

To equip yourself with an isolator for safe handling of your active and hazardous ingredients, you can turn without fear to one of the existing French manufacturers. Choose a high-performance isolator made in France, designed to comply with pharmaceutical industry classifications. Some manufacturers are able to provide you with tailor-made solutions.

Need a quote for an isolator for the pharmaceutical industry? Just contact us. We'll pass your request on to our partners, who will get back to you promptly.