Technical Capabilities
Our facility is engineered for precise formulation, tight process control, and manufacturing excellence under strict quality regimes.
Highest Quality Standards
All our sterile buffers and custom solutions are produced in line with current Good Manufacturing Practices. This commitment ensures:
- •Process Validation: Every critical manufacturing process is validated and routinely monitored to ensure consistent performance and reproducible results.
- •Change Control: A strict change management system is in place to assess the impact of any procedural or material modification before implementation.
- •Personnel Training: All technicians and QA staff receive continuous, specialized training in sterile handling and protocols.
- •Testing: We conduct extensive final product testing, including bioburden, sterility, pH, conductivity, and stability studies to ensure every batch meets our quality standards.
State-of-the-Art Manufacturing Environment
Our facilities are designed using pharmaceutical industry best practices to prevent contamination and guarantee sterility.
- •Controlled Cleanrooms: Manufacturing and filling operations are conducted within classified cleanrooms, utilizing positive air pressure and high-efficiency particulate air filtration systems.
- •Dedicated Equipment: We use dedicated stainless-steel vessels and single-use technologies to prevent cross-contamination between formulations, ensuring controlled processing and aseptic 0.2-micron filtration during filling.
- •Water System: Our Water for Injection (WFI) system is continuously monitored to meet quality parameter and pharmacopoeial standards for conductivity and microbial content.
Raw Material Sourcing and Qualification
We understand that buffer purity starts at the source.
- •Raw Material and Packing Material Qualification: All critical raw materials (salts, acids, bases, stabilizers) are sourced from approved suppliers and qualified against strict specifications, often requiring pharmaceutical-grade purity.
- •Lot Traceability: We maintain complete, bidirectional traceability for every component used in the final buffer formulation.