Pharmatec develops and manufactures various process plants for the production of pharmaceutical liquids.
We are the competent and experienced associate who will realise the special requirements for the process systems in an effective and cost-efficient way.
• for syrups, suspensions or parenterals
• no matter whether the process shall run manually or fully
automatic
• even with integrated CIP/SIP-systems
Our portfolio ranges from single “stand alone” systems e.g. movable agitator vessels with a net volume of 5 l up to complex built-in compounding and storage systems with a net volume of more than 20.000 l.
Beside the user requirements the fulfillment of national and international norms and standards as well as the GMP and FDA requirements are basis for our activities.
The
modular design of our systems as well as the use of well-established standard components from qualified sub-suppliers ensures an effective and innovative project handling within best time.
The optimal design of our systems avoiding dead legs guarantees excellent conditions for cleaning (CIP) and inline sterilisation (SIP) of the entire system.
By using
latest manufacturing technologies we are able to fulfill our customer’s highest requirements.
• In addition to materials like 1.4404 and 1.4435 (AISI 316L) which
are used as standard material for components that have contact
with the product we can also work with special materials like
1.4539
• The adherence of delta ferrite content according to BN2 can be
guaranteed without problems
• Surface roughness of Ra <0,5µm and/or electropolished is
nothing unusual for us
• Compact design with good access for maintenance reasons are a
standard for us
The process plants will be entirely pre-assembled and tested in Pharmatec headquarters’ workshop in Dresden. Beside the Black Utilities like plant steam, cooling water and compressed air, Clean Utilities like Purified Water, Water for Injection and Pure Steam are also available in our workshop. With these utilities the entire system can already be properly tested during FAT under real operation conditions.
This ensures that parts of the qualification can be executed in Dresden before shipment.
After the commissioning has been completed on site, Pharmatec will support the client with further qualification process of the system and on request we will guide them during the optimisation of the process steps.
Our references
