Aseptic Manufacturing Facilities for Injectable Drug Products
GRAM’s aseptic filling and finishing facilities encompass top-of-the-line design elements with advanced equipment. Our five GMP facilities accommodate customer and industry-wide demand for sterile manufacturing services. GRAM delivers reliable aseptic fill-finish services for clinical and commercial products.
Experienced staff serve clients in world-class facilities with top-of-the-line equipment and advanced technology in Grand Rapids, Michigan. Each facility follows cGMP compliance to ensure sterility, and our talented teams implement processes with maximum efficiency to produce exceptional results.
Three of our five GMP manufacturing sites were constructed after 2018, all with Annex 1 in mind. These facilities are highlighted below.
Sterile Filling and Lyophilization Facility
- 2021 Facility of the Year Awards Winner for Special Recognition for Operational Agility: COVID-19 Impact
- 80,000 sq ft and three floors
- Four Grade C formulation suites and four Grade C filling rooms
- Two Bausch + Ströbel 4-head Vial Fillers w/SKAN Isolators
- One Bausch + Ströbel VarioSys Vial and PFS Modular Filler w/SKAN Isolator
- One Bausch + Ströbel 8-head Vial Filler w/SKAN Isolator
- Lyophilization: IMA LyoMax 17 Lyophilizer
- CIP/SIP Suite
- Method Development, in-process and micro laboratories
- Just-in-time warehouse
- Stand-up frozen storage -70°C
- Walk-in frozen storage -20°C
- Walk-in cold storage +2°C to +8°C
Inspection, Finishing & Warehouse
- 200,000 sq. ft.
- Terminal sterilization with two autoclaves
- Four fully automated inspection systems
- Twelve semi-automated inspection systems
- Twelve manual inspection booths
- Three labeling and packaging systems
- Syringe labeler and assembly
- Weigh and dispense suite
- QC analytical and micro laboratory
- -50°C walk-in freezers
- -50 to -80°C stand-up freezers
- -20°C, -50°C walk-in frozen storage
- +2°C to +8°C walk-in finished product
- 2-8°C and -20°C walk-in in-process combination unit
- 20-25°C controlled room temperature storage
- 50,000 sq. ft. of material and finished product storage
- Future space for auto-injector/device assembly
New Syringe and Cartridge Filling Center
- 150,000 sq. ft. (Construction complete 4Q 2025)
- Grade C formulation suites
- Clean room space and utilities designed for up to 4 filling suites
- First fill line: GRONINGER syringe filler (Qualification 4Q 2026)
- In-line automated inspection
- Future space and utilities to support three additional fill lines and in-line inspection (total of four fill lines).
- Viewing rooms designed for customer transparency and access
- Filled syringes are to be packaged and stored at the adjacent Inspection, Finishing, and Warehouse Center