Integrated design and implementation of pharmaceutical manufacturing plants featuring latest containment technologies
In today’s pharmaceutical production, active pharmaceutical ingredients (APIs) need to fulfil high standards in terms of purity and efficacy. As a pure substance, many APIs are highly potent and require specific protection measures when being processed into pharmaceutical drugs in a strictly controlled environment.
Based on many years of experience and profound knowledge of the containment technologies available on the market, we develop individual containment strategies together with our customers. The primary focus of our solutions is to protect the operator in line with applicable Occupational Exposure Band (OEB) levels while at the same time meeting all cGMP requirements.
Which containment measures are appropriate?
io-consultants is your partner for efficient and safe concepts
In order to define appropriate measures, the Occupational Exposure Limit (OEL) of the API that is to be processed must be determined. This value describes the average air-borne concentration of the specific API that the operator is allowed to be exposed to during an 8-hour working shift.
Based on this value, the API can be assigned to an Occupational Exposure Band (OEB). This classification serves io-consultants as a basis to define potential technical measures.
Basically, it has to be decided during planning whether the containment is realized using open or closed systems. Both have specific advantages or disadvantages which need to be discussed and evaluated in order to create the appropriate, tailor-made containment strategy.
In order to improve the level of safety of their operators, most pharmaceutical companies tend to use closed systems – despite higher investment costs. However, the use of closed systems can lead to lower operating costs.
io-consultants provides you with the required advice and develops the most appropriate containment concept for you, considering the following aspects:
- Regulatory requirements and occupational safety
- Best available technology
- Process and cost efficiency
Expertise in containment technology is required for both oral solid or sterile liquid dosage forms. In both disciplines, we provide you with competent and integrated advice – from the initial conceptual ideas up to realization and qualification of the manufacturing suite. In that context, our pharmaceutical experts also analyze the potential of multi-purpose-rooms vs. partitioned process rooms in detail. Our experience with various challenges of successfully delivered projects is the basis of our targeted system evaluation and the implementation of both safe and efficient concepts.
Please contact us and discuss your project with our experts!
References
We offer reliable, productive and efficient solutions that lead to measurable success. Learn more about our successful projects with renowned clients around the world:
