Technical Capabilities
Our facility is engineered for precise formulation, tight process control, and manufacturing excellence under strict quality regimes.
Infrastructure
Our state-of-the-art facility is engineered to deliver pharmaceutical-grade solutions with uncompromising quality and reliability.
Capacity
10,000 L/Day
Facility Size
5,200 Sq. Yards
Capability
In-house Micro/QC lab
Certifications
ISO 9001, 14001, 45001
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.
- Change Control A strict change management system is in place to assess the impact of any procedural or material modification.
- Personnel Training All technicians and QA staff receive continuous, specialized training in sterile handling and protocols.
- Comprehensive Testing Extensive final product testing including bioburden, sterility, pH, conductivity, and stability studies.
State-of-the-Art Manufacturing
Our facilities are designed using pharmaceutical industry best practices to prevent contamination and guarantee sterility.
- Controlled Cleanrooms Manufacturing and filling operations utilize positive air pressure and high-efficiency particulate air filtration.
- Dedicated Equipment Dedicated stainless-steel vessels and single-use technologies to prevent cross-contamination and ensure aseptic processing.
- Water System Continuous monitoring of WFI systems to meet pharmacopoeial standards for conductivity and microbial content.
Raw Material Qualification
We understand that buffer purity starts at the source.
- Strict Qualification All critical raw materials (salts, acids, bases) are sourced from approved suppliers and qualified against strict specifications.
- Lot Traceability Complete, bidirectional traceability for every component used in the final buffer formulation.
