|
Pharmatec is an expert manufacturer of CIP systems with a long experience in the field of pharmaceutical and biotechnological engineering.
We are developing tailor-made cleaning systems (CIP/SIP), which are adapted to your individual requirements.
• for cleaning buffer preparation systems, fermenting or filling
machines
• for mobile or fixed installed single tank systems or a more
complex multi tank system
• for cleaning via circulation or via single use
• it is also possible to completely integrate the units into the
process system that has to be cleaned
The use of special dosing, heating and cooling systems guarantees a constant cleaning quality on a very high level.
Beside the user requirements the fulfillment of national and international norms and standards as well as the GMP and FDA requirements are basics 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 design of our CIP systems avoiding dead legs provides excellent conditions for the self-cleaning of the system. Of course these systems can also be designed for inline sterilisation (SIP).
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 CIP-units will be entirely pre-assembled and tested in our headquarters’ workshop in Dresden. Besides 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.
|