Engineering - Pharma

PW- & WFI-systems

Wellmann Engineering supplies high quality systems for the distribution of AP (“Aqua Purificata”), WFI (“Water for Injection”) and pure steam.

The cleaned medium is stored and then transported in a distribution system up to the extraction points.

Wellmann Engineering develops individual process systems according to each customer´s requirements always with product safety in focus. We offer solutions for cold and hot storage. The distribution through ring pipe systems (Loops) ensures a turbulent flow and the hygienic design without dead spots prevent the formation of germinals and bacteria.

Our systems are completely made of stainless steel and are orbital welded. In combination with control systems developed by our automation experts a high degree of product safety is ensured.

Scheduled sanitisation of the entire storage and distribution systems is processed either cold (by addition of ozone) or hot (by heating to >85°C).

Formulation system

In the production of active ingredients in formulation systems sterility is a crucial factor for product quality. Wellmann Engineering offers high-quality formulation systems for liquid or semi-solid products as liquid drugs or cosmetics. The vessels are completely manufactured in high quality stainless steel. A hygienic design without dead spots ensures highest product safety.

Cleaning in Place

Usually CIP systems are fully automated, with fixed defined cleaning programs and variably adjustable temperatures.

Due to the high degree of automation a faster cleaning, water and detergents reduction and less effort is achieved. CIP systems are fixed units and require little or no assembly / disassembly work. By a programmed pre-purge particles are flushed out. The cleaning temperature is around 90°C depending on specific applications. After flushing, the pipelines and components are pumped with lye. After flushing with water, a final acid rinsing proceeds.

Implementation of purified water

The production of “Aqua Purificata” (= purified water) from drinking water according to Ph. Eur. And USP requires procedural processes according to the highest hygiene standards.

The production of high-purity AP water takes place through the process steps of softening, reverse osmosis and electrodeionization.

The individual measurement and control concepts developed by our automation specialists ensure continuous and efficient monitoring of performance and water quality even after long operating times.

All plants are documented and qualified according to international standards.

Qualification & Validation

The manufacture of products in the pharmaceutical or food sectors is increasingly subject to detailed regulatory requirements and must comply with IFS, FDA or European standards. These plants almost always require validation. As a plant operator, you must demonstrate for this that, within your entire process control technology, you work in accordance with specifications and your work can be reproduced.

We have taken these requirements into account in all phases of the qualification. We are at your disposal at any time during the design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) phases.