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 systemsdespite 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!

io-consultants – your lead consultant for containment projects

Award-winning projects for our clients

After receiving the „ISPE Facility of the Year“ award 2008 (categories Overall Winner and Process Innovation) for one of our last projects, we could win a project with our customer Merck KGaA as lead consultant. The project task was the design and the realization of an oral solid dosage form GMP pilot plant handling APIs up to OEB 5.

The challenge was to realize an R+D clinical supply  manufacturing unit for batch sizes of 0.5 to 30kg in a closed system (isolator technology) in an existing, extremely space-restricted building, using various granulating technologies and completely closed material transport (up to OEB 5).

The technology chosen was the latest in containment and solids handling, thus allowing a well-balanced relation of optimum personal safety on the one hand and conformity with GMP requirements and regulations on the other hand.

The final result was based on our many years of containment experience as well as the unique combination of our in-house expertise in the fields of process design, GMP, IT and process automation.

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:

Please contact us 

© photo by www.danilofloreani.com
Tim Walter Business Unit Manager Phone: +49 (0) 62 21 / 379-111 tim.walter@io-consultants.com