Containment in the pharmaceutical industry – protection concept for people, products, and processes
Last updated: 16 December 2025
Pharmaceutical manufacturing is subject to high demands. Manufacturers aim to produce pharmaceuticals and cosmetics not only efficiently and cost-effectively but must also comply with protection measures to contain cross-contamination, as employees and the environment are exposed to harmful influences during production. Therefore, various containment strategies have been developed to protect people, the environment, and products.
What does Containment mean?
The term “Containment” in the pharmaceutical context refers to the controlled enclosure and limitation of substances—especially highly potent or toxic active ingredients—within defined processes and areas. The goal is to prevent the spread of these substances within equipment, rooms, and onto personnel, thereby protecting product, staff, and environment. Containment includes both technical solutions (e.g., isolators, glove boxes, closed transfer systems) and organizational measures and suitable spatial concepts.
Within the framework of Good Manufacturing Practice (GMP), containment is a central technical tool for preventing cross-contamination and ensuring product quality. Although the term “containment” is not consistently used as an independent term in the EU GMP Guide, the revised Annex 1 on the Contamination Control Strategy (CCS) explicitly calls for well-defined measures to limit product exposure and cross-contamination. These risk-based, controlled processes and technical barriers serve to protect personnel, products, and the environment.
In addition, effective containment measures help minimize emissions and wastewater, thereby meeting site-specific environmental regulations—such as limits on emissions or the treatment of pharmaceutical process wastewater.
In principle, active and auxiliary substances in production are enclosed so that they cannot be released uncontrollably into the environment. Depending on the active ingredient, even very small amounts can be critical; therefore, allowable exposures are described by Occupational Exposure Limits (OEL) and derived Occupational Exposure Bands (OEB). An effective containment strategy thus protects employees from exposure, the product from contamination by humans, and other products from cross-contamination.
Containment solutions range from simple to complex protection systems to prevent contamination. These include glove boxes, cleanroom bags, or isolators. Increasing demands and stricter industry regulations compel manufacturers to pay particular attention to containment. With the amendment of the Hazardous Substances Ordinance, which came into force on December 5, 2024, occupational safety was further strengthened. The risk-based measures concept from TRGS 910 (“traffic light model”) was legally established and places greater focus on systematic risk assessment and stepwise protective measures.
Distinction: Primary and Secondary Containment
Containment solutions are divided into primary (direct) and secondary (room-related) measures.
Primary containment includes all technical precautions that prevent direct contact of substances with the environment or personnel—such as closed containers and systems, isolators, glove boxes, or endless liner systems.
Secondary containment refers to room- and building-related measures such as cleanrooms, airlocks, or pressure cascades. These prevent substances that are released despite primary barriers from spreading further in the building and thus contribute to the safety of people and the environment.
Key Terms: OEL and OEB
The concepts of OEL and OEB frequently appear in the context of pharmaceutical production. Both terms serve to assess potential hazards that are also relevant for containment strategies.
OEL (Occupational Exposure Limit) describes the maximum permissible concentration of a substance in workplace air that a person may be exposed to during an 8-hour shift (or 40-hour week) without risking health impairment. OEL values form the basis for technical protective measures such as isolators or closed transfer systems.
OEB (Occupational Exposure Band) categorizes substances based on their toxicology. Typically, they are divided into five to six levels (OEB 1–5, sometimes 6), with the highest level representing the greatest risk. This classification correlates with certain OEL ranges and helps determine the required containment level. Note: the bands are not standardized and may vary by company.
Practical Example: FLECOTEC ZIP Containment System
Containment solutions may be designed for specific products and their manufacturing processes or may be flexible and applicable to various products. The latter applies to the FLECOTEC ZIP Containment System by Rommelag FLEX. This solution meets containment level requirements up to OEB 5. The exact containment performance—including classification up to OEB 5—is documented in Rommelag FLEX’s technical specifications and validation documents and can be provided upon request.
The containment bags are made of pharmaceutical high-performance film with integrated ZIP components, connected by a slider. The zipper mechanism enables a highly tight, validatable connection between two process steps. Thus, the active ingredients contained within are isolated and can be safely and controllably handled and transported—for both humans and the environment—when used correctly and under validated processes.
Advantages of Containment for the Pharmaceutical Industry
A comprehensive containment strategy is an important component for meeting Good Manufacturing Practice (GMP)requirements. These regulations, standards, and guidelines serve to protect products, people, and the environment. By preventing direct contact between operators and hazardous substances, employee health and safety are ensured. Employees feel safer and more relaxed at work. Manufacturers save unnecessary costs by avoiding product recalls through compliance with containment measures. They also avoid liability for health or environmental damage. Otherwise, contamination could result in products being ineffective or even harmful to consumers. Thus, there are also economic reasons for compliance with containment solutions.
Additionally, single-use containment systems, such as FLECOTEC ZIP, reduce cleaning and validation effort and prevent the so-called “Ring of Concern” at transfer points.
Challenges and Risks of Containment
The implementation of containment measures places increasingly high demands on manufacturers. It requires careful planning and regular evaluation. Manufacturers must decide whether to adopt new technical solutions or apply different standards. Transitioning to new containment solutions also incurs additional costs. Regularly updated GMP and cGMP guidelines require controlled processes and documented evidence.
Outdated equipment and production facilities may need to be modernized or replaced. Containment solutions may also include systems for ventilation, dedusting, or cleaning. Comprehensive documentation also includes qualification, validation, monitoring (e.g., pressure cascades, leak tests), and training of personnel.