Chempharm is proud to have played a pioneering role in establishing India’s first EU-certified Eye Care Cleanroom for Stericon’s Ophthalmic Plant in Bangalore. This cutting edge facility focuses on the production of soft contact lenses and contact lens cleaning solutions, providing innovative solutions to the ophthalmic industry.

India’s Only EU-Certified Ophthalmic Plant
This plant is the first ever Indian ophthalmic plant with EU certification and CE-certified product lines, distinguishing it in the global market. This prestigious certification is the validation of the plant’s compliance and adherence to the highest quality standards in both product safety and manufacturing processes.

Chempharm’s Role in the Project
Chempharm played an essential part in the design and implementation of Stericon’s manufacturing facilities. The project began in 2010 with the construction of the first 60,000 sq. ft. cleanroom facility, built to meet stringent international regulatory standards.

Following the success of the first plant, Mr. Divakar, the Chairman and Founder of Stericon, awarded Chempharm a repeat order to develop a second production line with an additional 36,000 sq. ft. of cleanroom space. Both facilities were built and set up in compliance with EU GMP standards and produce CE-certified products, ensuring the highest levels of cleanliness, sterility, and efficiency.

Certifications and Compliance

Both of Stericon’s ophthalmic facilities are EU-certified while holding the following industry-leading certifications as well:

• ISO 13485: An international standard for the design and manufacture of medical devices.
• CE 2460 Certification: Awarded by DNV GL Presafe, Norway, ensuring that the products meet European safety, health, and environmental protection requirements.

These certifications reflects Stericon’s commitment to delivering safe, high-quality products for the global ophthalmic market, while also showcasing Chempharm’s ability to design and implement world-class facilities that meet the most rigorous international standards.

A Partnership Built on Excellence

The partnership between Stericon and Chempharm exemplifies trust and excellence. The facilities, designed to meet EU GMP and CE standards, are at the forefront of ophthalmic product manufacturing in India. ChemPharm’s contributions, from the concept to conception, have solidified its reputation as a leader in delivering turnkey cleanroom solutions for the industry.

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