DIRECT-TO-FILL DIRECT-TO-FILL D2F Direct to Fill STERILIZED PACKAGING SOLUTIONS Nests and Tubs Are First Cleaned with Ionized Air to Minimize Particle Load

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Pharmaceutical Packaging industries. Packaging Pharmaceutical and Device, Medical Pharmaceutical, the serves Nipro worldwide, employees 27,000 over with company healthcare global aleading As 1954. in established Japan, Corporation of Nipro part is PharmaPackaging Nipro to your customers. administration healthier and a safer to you provide enables PharmaPackaging Nipro services, and products, personnel, our Through platform. service an exceptional offers PharmaPackaging Nipro services, lab internal and offices, sales multiple of 16 footprint plants, manufacturing a worldwide With drugs. existing for solutions of enhancement packaging the or drugs development early for solutions packaging complete and products packaging pharma advanced manufacturing and indeveloping specialized is PharmaPackaging Nipro Blokhuisstraat 42, 2800 Mechelen, Belgium | Belgium Mechelen, 2800 42, Blokhuisstraat NIPRO PHARMAPACKAGING INTERNATIONAL HEADQUARTERS [email protected] | [email protected] www.nipro-group.com

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DIRECT-TO-FILL DIRECT-TO-FILL D2F Direct To Fill STERILIZED PACKAGING SOLUTIONS Nests and tubs are first cleaned with ionized air to minimize particle load. Robots load the washed glass vials into nests Nipro PharmaPackaging manufactures D2F™ vials in technologically advanced production sites that are certified according to ISO 9001, ISO 15378, and tubs. The tubs are covered with a Tyvek® insert, sealed and ISO 14001. Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with GMP 100% monitoring under laminar air flow. with a corresponding Tyvek® lid, and then entered into a breather bag which is welded closed (double inserts & breather bags optional). Tyvek® lid Our 100% in-line inspection system allows for continuous quality monitoring as part of In Process Controls (IPC). This Tyvek® insert Welded breather bag ensures that all tubs are 100% filled and correctly sealed. 2 1 Afterwards, machines transfer the tubs to a station for final Sealed tub packing. Tubs are stacked and placed in outer boxes. Outer boxes are placed on pallets, protective angle boards are applied, and fixation is ensured with PE-Bands. The total pallet is wrapped in plastic foil to ensure safe transportation.

Final packed glass vials are then EO sterilized. Labels on the tubs and outer boxes are provided with a special EO indicator 3 Cardboard or PP-Well interlayers (a color change from blue to green after EO exposure). 6 per outer box Nest This allows for visual confirmation of EO sterilization and subsequent exposure.

Stacking scheme1 KEY TECHNOLOGIES Tub 15 tubs per outer box; 5 layers; 3 tubs per layer, packed upside down Label with EO indicator

100% camera inspection Packing scheme2 10 outer boxes per pallet; 2 layer; 5 outer boxes per layer 5

Label with EO indicator PE-Bands EO

Outer Cardboard or PP-Well Box 800 x 530 x 240 mm No glass-to-glass contact Intelligent label Angle boards (PE-Film) PE-cover sheet (optional)

Nipro’s D2F™ packaging design is a smart, efficient choice. Plastic, wooden or treated wooden pallet It prevents glass-to-glass contact while enabling immediate

1. Different stacking schemes available (depending on type of tub). 800 x 1200 mm and direct use on the filling line. In essence, Direct-to-Fill. 2. Multiple pallet schemes available.