Containment in vogue: regulations demand sophisticated protection concepts for pharmaceutical and chemical production

What is containment?

In the pharmaceutical and chemical industry, the term containment describes safety measures that are used to protect employees and products from hazardous substances. These are systems and technologies that help to minimize contact between people and toxic substances and prevent the spread of hazardous substances in the environment.

What are the protection goals of containment solutions?

The main objectives of containment are to protect employees and ensure product quality. In the chemical industry, the focus is on occupational safety, whereby hazardous substances are kept in the plant by hermetically sealed systems or separated in filters to prevent exposure. In pharmaceutical production, the product itself must also be protected from external influences and contamination.

What are the advantages and disadvantages of containment compared to personal protective equipment?

The use of containment systems offers several advantages over the use of personal protective equipment (PPE), such as full protective suits and respirators. Containment systems separate employees from the hazardous product, greatly reducing the risk of exposure. This is particularly important for highly active and toxic substances where the limits are pushed into the nanogram fraction range.

Although containment systems can initially be perceived as expensive, they save costs in the long term as expensive product losses are avoided and productivity is not affected. Employee safety and product quality are also improved, reducing the risk of recalls and reputational damage.

What do the new GMP Annex 1 and the REACH regulation say about containment?

GMP Annex 1, which regulates the manufacture of sterile medicinal products in Europe, was revised between 2017 and 2022 and has been in force since August 2023. The new version emphasizes the importance of containment systems: The new Annex 1 elevates RABS (Restricted Access Barrier Systems) and isolators to the means of choice to minimize microbial contamination from direct human intervention. Companies must now carefully consider whether containment should be included in their contamination control strategy.

The REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) imposes registration obligations on companies that manufacture or import hazardous substances and sharpens the focus on occupational health and safety. Containment is also seen here as a preferred technical measure for the protection of employees and the environment.

What is meant by OEB and OEL?

The abbreviation OEB stands for "Occupational Exposure Band" and is a measure of the toxicity of a substance. The higher the OEB level, the more toxic the substance in question and the stricter the safety measures and containment systems required to minimize employee exposure. OEB 1 and 2 describe a low toxic potential, while OEB 4, 5 and 6 stand for a high toxic potential.

OEL stands for "Occupational Exposure Limit" and is therefore a workplace limit value that is used in the chemical and pharmaceutical industries in particular to define the permissible concentration of a chemical or substance in the air at the workplace. The OEL value specifies the concentration of a particular substance in the air at the workplace at which no acute or chronic damage to the health of employees is to be expected. These values are usually measured in micrograms per cubic meter (µg/m³) or parts per million (ppm).

How do OEB and OEL differ?

The difference between OEB (Occupational Exposure Band) and OEL (Operator Exposure Limit) lies in their respective function in assessing the toxicity and exposure of substances in containment applications. OEB is a classification that describes the degree of toxicity of a substance on a containment scale. It evaluates the toxicity of the pure substance regardless of the environment or exposure. The OEL is based on a specific measurement of exposure in a particular working environment. An example to illustrate: An OEB-5 corresponds to an exposure of less than 1 µg/m3. This means that a concentration of less than 1 microgram of the substance per cubic meter should be present in the air at the workplace in order to protect the health of employees.

Cost-optimized containment solutions require an individual approach

When selecting an optimal containment solution, it is important to consider both parameters – OEB and OEL. Measuring the OEL alone can lead to oversized systems and increased investment costs. A comprehensive understanding of the process is therefore essential in order to develop an efficient and safe containment solution that meets the requirements of OEB and OEL.

Conclusion:

The trend towards increasingly toxic substances and active ingredients, as used not only in the pharmaceutical industry but also in new areas such as battery production, and the simultaneously increasing requirements for the protection of operating personnel ensure that the need for containment solutions is growing. The topic therefore played a major role at POWTECH 2023: numerous companies showcased corresponding solutions, which we present in a separate article. It became clear that containment is not just a trend, but an indispensable measure in an increasingly demanding and regulated industry.