Our Sterile Skid / Injectable Processing Plant is meticulously designed and manufactured to meet the stringent requirements of the pharmaceutical and biopharmaceutical industries. With capacities ranging from 5 liters to 30,000 liters, this system is ideal for the production of sterile solutions, vaccines, injectables, human insulin, serums, aerosols, ampoules, and plasma fractions.
We leverage our extensive experience and adhere to global standards such as ASME BPE, GAMP, PED, and USFDA to deliver a reliable and compliant solution for your critical sterile manufacturing needs.
Features
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- Capacity Range: Available in sizes from 5 liters up to 30,000 liters to suit various production scales.
- Versatile Applications: Suitable for a wide array of sterile product manufacturing, including pharmaceuticals and biopharmaceuticals.
- Aseptic Design: Mixing and blending vessels are specifically designed to maintain sterility throughout the process.
- Compliance with Standards: Engineered and manufactured in accordance with ASME BPE, GAMP, PED, and USFDA guidelines.
- Â Bottom-Mounted Magnetic Mixers: Ensures efficient and hygienic mixing, meeting stringent aseptic requirements.
- Customized Engineering: Designed and engineered to seamlessly integrate with your existing facility layout and specific process requirements.
- Integrated CIP/WIP/SIP System: Features a comprehensive Clean-in-Place (CIP), Wash-in-Place (WIP), and Sterilization-in-Place (SIP) system with 100% drainability for optimal hygiene.
- In-House Automation Expertise: Our skilled team provides customized programming to design specific cycles and recipes tailored to your process.
- Advanced Automation: Implements automation compliant with 21 CFR Part 11 and GAMP guidelines for data integrity and process control.