Pharmaceutical Production

Solid, semi-solid, liquid, sterile and non-sterile. Chemgineering plans and optimizes your process and implements it technically. From development to packaging.

Solid forms - discovering potential for improvement pays off

Margins are low in the production of pharmaceuticals in solid dosage form (tablets/film-coated tablets, coated tablets, capsules, sachets, etc.) or in semi-solid or non-sterile liquid form - which often tend to be in the lower price range. Many manufacturers therefore shy away from upcoming investments. However, this view of things often means that sensible and necessary modernization measures are put on hold, and at best only the minimum required by the authorities is implemented.

In national and international competition, however, it is vital to have the decisive production advantage on your side.

Optimizations in the pharmaceutical production process do not necessarily require high investments. Often, organizational means alone, such as optimizing the quarantine strategy, can increase the efficiency and thus the capacity of production.

There is further potential for optimization, for example through:

• Changes to the product range and the resulting better utilization of in-house resources.
• Acceptance of contract orders or outsourcing of "exotic" products with low machine utilization rates and comparatively higher cleaning costs.
• Optimization of material and personnel flows.
• Shortening batches and cleaning times by upgrading existing equipment.
• Modernization of technical building systems.
• Acquisition of new process systems or even the construction of a complete new production facility on a greenfield site - these can also pay for themselves within a very short time.

Sterile forms - tailor-made solutions for pharmaceutical finishing

Although the production and application costs of sterile liquid forms are significantly higher than those of solid dosage forms such as tablets or capsules, the treatment of certain diseases is still only possible with drugs that bypass the digestive tract (parenteral application). Biotechnologically manufactured products such as proteins, hormones, blood clotting factors and mRNA vaccines are becoming increasingly important in the pharmaceutical industry. At the same time, the regulatory requirements for modern sterile production are increasing.

The focus is on the definition of the process. Each individual process step is analyzed with its critical process parameters, from weighing to preparation, filling and final packaging. Wherever the product is processed openly, special care must be taken in planning. Suitable materials must be selected specifically for system parts that come into contact with the product and media in order to ensure a safe manufacturing process.

Decisive steps for creating a modern sterile manufacturing process in pharmaceutical production include:

• GMP risk analysis to identify critical process steps and derive measures and process equipment.
• Containment analysis to define the necessary barriers, especially for highly active substances, and to harmonize product protection, plant flexibility, accessibility and personal and environmental protection in the best possible way.

Based on this holistic planning process, a customized cleanroom and layout concept is created that precisely meets the requirements of modern sterile production.

Pharmaceutical packaging - Cost-efficient qualification

Chemgineering offers a great deal of experience and expertise in the qualification of packaging systems. The aim here is to ensure that a system works reproducibly and that the quality of the product is not impaired in any way. If this is chosen as the basis for qualification, it quickly becomes apparent that there are relatively few individual parameters critical to product quality in packaging systems compared to other manufacturing processes (e.g. control and printing systems). This is where chemgineering comes in: The documented qualification of such systems concentrates on the parameters that directly influence quality (GMP-relevant).

Additional requirements that have no direct influence on product quality (e.g. safety, business requirements, etc.) are tested as part of Good Engineering Practice GEP (planning quality), but are not subject to the same level of documentation as the GMP (quality) relevant aspects. The result is a cost-effective, time-saving and easy-to-handle qualification.

One contact for all pharmaceutical production issues

At Chemgineering, we have the know-how to master the current challenges of the pharmaceutical industry as a team with our customers - be it the conversion or new construction of a production plant or entire factories or the qualification of plants, e.g. in pharmaceutical packaging.

During the concept phase and basic engineering, we develop the right solution for your task. As a neutral technology consultant, we cooperate with almost all system providers and are always informed about the latest developments. Our knowledge of the market and suitable suppliers leads to the optimum implementation of the planning concept. Regulatory requirements and cGMP requirements are met without any ifs and buts, and the technical solutions are selected in such a way that function and economy are at the forefront.