Contract Manufacturing
Quality Control and Assurance
Regular water analysis is conducted, including Phase 1, Phase 2, and Phase 3 testing, with yearly trend analysis to ensure the highest standards of quality.
During monsoons, the frequency of RW/WFI testing is increased to ensure compliance with regulatory requirements.
Additionally, media fill tests are performed on our entire manufacturing system as per approved protocols to guarantee sterility and cleanliness.
We prioritize quality control and assurance in every step of our contract manufacturing process.
Facility Design and Equipment
Our state-of-the-art facility is designed to meet the most stringent regulatory requirements. The walls and ceiling are constructed with 80 mm thickness, double skin powder coated material, and the flooring is coated with 3 mm epoxy.
The surrounding wall structure is made of RCC using Autoclaved Aerated Cement Blocks (AAC Blocks). Our core filling area is classified as Class A/B, continuously monitored with particle counters to ensure a sterile environment.
Manufacturing Capabilities
We offer a range of manufacturing capabilities for injectables, including ampoules and vials. Our filling machines are equipped with MET-ONE online particle counting machines to ensure accurate counting and monitoring. We can fill ampoules in various sizes (1 mL to 25 mL) and vials (2 mL to 100 mL), including multi-dose products in 100 mL vials.
Flexibility and Customization
Every product has unique requirements. That's why we offer flexible manufacturing options that can be tailored to meet your specific needs. From formulation development to final packaging, we offer end-to-end contract manufacturing solutions for injectables that cater to your specific needs.
With our expertise in filling ampoules and vials in various sizes along with blister packing options, we provide a comprehensive range of services that help streamline your production process while ensuring high-quality products that meet regulatory requirements.
