We have been working closely with the pharmaceutical industry for decades. We supply PTFE and PFA Process Components to our customers, globally.
All the raw materials we use, meet the strict criteria of USP Class V1 and they are also ADI-Free.
Regulations continue to become more stringent in the pharmaceutical sector and the demand for process component materials to aid the research and manufacturing of drug products is ever-increasing.
That is why we continue to develop and keep up to date with the latest rules and regulations. We maintain continuous quality control checks, keep seamless documentation and use our own clean room in accordance with ISO 14644-1 Class 5 to guarantee high process reliability in the pharmaceutical and medical technology field.
A great example of our products in use with the pharmaceutical industry is with a dialysis device. The dialysis agent is supplied directly to the device through a precisely controlled electrical ball valve. There is also the option to have the agent filtered during this process. Series 7F filters offer various filter grades in this instance. The Reliable Luer-Lock adapters can supply the dialysis device as well as removing used dialysis agent.
Our plastic products which include Tri-Clamps, Couplings and Ball Valves, create a “soft” application by using connectors and flexible tubes made from PVDF, PFA and PTFE, which are all FDA-compliant and easy to disassemble. The machines, which must be FDA-compliant in production, must produce cold wax strips for hair removable and have been used in the past with metal parts which are not compliant.
There has been a historic difficulty with changing these parts as they haven’t been easy to disassemble which is why our plastic components are a much better alternative to metal components.
Using flexible tubing also has other advantages, such as reducing the system vibration caused by dosing pumps. These pumps pulsate through the diaphragms in the application and, depending on how large the flow is, the dosing pump moves (vibrates) faster or slower. The faster the pump moves, the greater the flow. This increases the probability that the fixed application could break. Therefore, our flexible tubes are a much safer, easier and more efficient alternative.
Our connectors are integrated with many cleaning systems due to their high resistance to media. This helps our customers to easily maintain CIP (Clean in Place) standards for their production systems. This method helps the pharmaceutical industry to ensure the safe supply and removal of chemical cleaning agents.
Today CIP cleaning is considered a standard cleaning method for production systems in the pharmaceutical industry. This is a process that cleans the interior of pumps, vessels, process equipment, filters and fittings without prior disassembling, opening or manual involvement.
We offer suitable connectors for any type of cleaning process: Our products made of PVDF and PFA are also suitable for hot steam sterilisation, the indispensable requirement for absolute sterility. PVDF is also autoclavable with no concerns at 134°C. PP and PEEK can be sterilised with γ radiation while fully retaining their mechanical properties (maximum dosage 25-50 kGy). PVDF is non-toxic in the range <150°C and does not provide any breeding ground for microorganisms. The surface of PVDF behaves very similarly to glass.