Parenteral Formulation Compounding
TECNinox faces up to these challenges.
What do we want out of each of our project? Do we want a project that has problems during planning, engineering, construction, validation and operation? Do we want a client that is not satisfied? Of course not. We want a customer/client that is happy and satisfied. Generally, this means that for this customer /client the project is within budget, on schedule and provide better than expected results. Getting there can be a battle, that must be won by the synergy between our experiences engineer and your project team. Every detail of the design has to meet high quality standard demand, in order to reduce validation requirements and subsequent headaches. Whatever your process conditions might be, we will provide anywhere worldwide the right solution, with the highest European/American standard of quality and reliability. With the flexibility you need and in the best fitting size.
Common features for Parenteral applications
• Fully drainable, crevice free design, no dead leg
• Minimisation of product losses by the use of block valve
• Use of aseptic sampling device
• Minimisation of product sedimentation by the use of RSTBV
• Flush mounted tank sanitary clamp — TK connect mounted on the top head of the tank
• Completely suitable for in-line CIP and SIP
• Fittings according to ASME BPE
The system design for high-quality production for parenterals/bioprocess application typically includes both Clean-In-Place (CIP) and Steam-In-Place (SIP) requirements. CIP and SIP operations are complementary. Good cleaning is essential to the SIP operation because it removes residual soil that could harbour microbes from steam contact during sterilization. Conversely, sterilization is often required prior to CIP to deactivate biohazards in the equipment. Stated simply, TECNinox engineers recognize the benefit in the recognition of parallel design requirements for CIP and SIP, that can lead to an integrated solution that results in an optimized equipment design.
Design, construction, validation for sterile processing
TECNinox is leader in providing advanced processing solutions for liquid form to the pharmaceutical solution. We design and build according to Specifications & Requirements for sterile design following cGMP, GEP. TECNinox offers a wide range of solutions, from individual pieces of equipments to complete integrated plants.
By knowing the latest components and valve technology, it allows to establish the design using reasonable and appropriate requirements /criteria.
The systems can be supplied as Built-In-Place or as ready-to-use process modules. Ready-to-use or “plug & play” process modules can be supplied pre-tested in a FAT, pre-IQ one pre-OQ. This type of pre-tested modules gives the client great advantages, reading the total condition time of green field project considerably and minimizing down time during installation of new modules in existing process line.
TECNinox has the experience and know-how to help and find the optimal solution for your liquid processing. We are a well-reputed supplier of all types of liquid formulation processes, for pharmaceutical:
Injection solution / Infusion solution / Suspension / Ophtalmic solution / Parenteral solution / Coating solution
System control options range from simple, manual push-button control to full programmable logic controller ( PLC ) based SCADA options offering a wide range of recipe handling, data acquisition and networking functions. The system comply with all current industry standards like 21CFR par 11 and standard communication ensure full compatibility with existing control strategies and plant-wide supervisory systems.