The first floor (Level 2) is dedicated to the production of sterile and ophthalmic products, with an independent material loading and unloading area. This level also features an advanced HVAC system that provides precise climate control, which is essential for maintaining the sterility of products. The facility is equipped with a high-purity water distribution system, ensuring that the necessary water quality is maintained for sterile production. Additionally, comprehensive firefighting equipment is in place to manage potential hazards and protect personnel and product integrity.

The General Sterile and Ophthalmic Unit adheres to Good Manufacturing Practices (GMP) and is certified by the Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare, Government of Bangladesh. HPL continuously prioritizes GMP compliance, aligning with international standards to ensure the safety, efficacy, and quality of every product manufactured.

The product range produced in the General Sterile and Ophthalmic Unit includes liquid injections, lyophilized injections, prefilled syringes, and ophthalmic products. The facility is equipped with the latest pharmaceutical manufacturing technologies, and the production process is carried out by a highly skilled workforce committed to operational excellence. The HVAC system within the unit plays a critical role in maintaining strict environmental controls, preventing cross-contamination, and ensuring the optimal conditions required for sterile product manufacturing.

HPL’s Quality Management System (QMS) for the General Sterile and Ophthalmic Unit is in compliance with global regulatory guidelines, such as EudraLex Volume 4 and 21 CFR 210 & 211. The QMS incorporates key quality management tools such as Deviation Management, Change Control, and Quality Risk Management, all of which are rigorously monitored through digital platforms including eQMS, DMS, and LMS. This ensures product quality and compliance, with finished products released through SAP for enhanced traceability and accountability.

The General Sterile and Ophthalmic Unit also prioritizes environmental sustainability and operational safety. It is equipped with advanced water treatment systems to provide high-purity water necessary for pharmaceutical applications. Fire safety measures are integrated across the facility, with firefighting and detection systems on each level, ensuring the protection of personnel and assets. Designed with sustainability in mind, the facility fosters a clean, safe, and environmentally responsible workspace.

With its commitment to innovation, a skilled workforce, and adherence to international quality standards, HPL’s General Sterile and Ophthalmic Unit remains at the forefront of sterile product manufacturing, dedicated to providing safe, effective, and globally compliant healthcare solutions.