Itami Plant

Manufacturing Site for Injectables and Liquids

With the aseptic product manufacturing technology that we have accumulated for more than 80 years, the Itami Plant can provide comprehensive services, from the manufacturing of clinical trial drugs to commercial products, as a manufacturing site for high potent and non-hazardous injectables and liquids.Equipped with manufacturing facilities for injectables using drug delivery system (DDS) technology, it can develop and manufacture high-value-added drug products through the fusion of aseptic product manufacturing technology and DDS-based formulation manufacturing technology.With technical capabilities that we have gained over many years, we provide our customers with a sense of security and smooth launch.

4-323 Senzo, Itami City, Hyogo 664-0898, Japan
TEL +81-72-778-7501

Japan

PMDA

High Potent Injectables Manufacturing Building

Non-Hazardous Injectables / Liquids Manufacturing Building

High Potent Injectables Manufacturing Building

Formulation

Itami Plant High Potent Injectables Manufacturing Building

With two manufacturing lines for high potent injectables (manufacturing line for vial injectables / manufacturing line for vial lyophilized injectables) that can handle high potent injectables with a hazardous level of up to 5 (OEL 0.15 μg/m³), we can provide injectables in glass vials as well as plastic vials.
In addition, advanced cross-contamination prevention with the latest single-use system and advanced nitrogen replacement in the vial headspace with a vacuum capper are possible.
The High Potent Injectables Manufacturing Building meets the requirements of three-region (Japan, USA, and EU) GMPs and PIC/S GMP and is capable of advanced product manufacturing.

Major Facilities

Weighing	Negative pressure isolator for weighing Available for OEL 0.15 μg/m³
Solution Mixing	Solution mixing tank (100 L, single use)
Filling	＜Manufacturing line for vial injectables＞ Plastic vial exterior decontamination box, Vial washer sterilizer, Vial filling stoppering machine Isolator specification 50 vials/min (φ24.3 mm) ＜Manufacturing line for vial lyophilized injectables＞ Vial washer sterilizer, Vial filling stoppering machine Isolator specification 38 vials/min (φ24.3 mm)
Lyophilization	＜Manufacturing line for vial lyophilized injectables＞ Lyophilizer, Automated vial loading systems Isolator specification: Positive pressure control (sterility guarantee) at the time of acceptance, Negative pressure control (containment) at the time of delivery 11,552 vials/equipment (φ24.3 mm)
Capper	＜Manufacturing line for vial injectables＞ RABS specification 50 vials/min (φ24.3 mm) ＜Manufacturing line for vial lyophilized injectables＞ Isolator specification 38 vials/min (φ24.3 mm)
Washing	Exterior washer

Manufacturing line for vial injectables

Manufacturing line for vial lyophilized injectables

Inspection / Packaging

Shrink / tack label packaging combined machine

For packaging, the use of shrink labels and of protectors at the vial bottom makes it possible to prevent vials from breaking and prevent drug solution from scattering.
It is also possible to meet the need for drug exposure prevention in medical settings by adopting a packaging design with a cushioning function for preventing vial breakage.

Major Facilities

Inspection	100% visual inspection
Packaging	Shrink / tack label packaging combined machine 35 vials/min (φ24.3 mm)

High Potent DDS-based Injectables

Since we started the contract manufacturing of high potent DDS-based injectables in 2004, we have accumulated a track record of manufacturing more than 15 items.
The High Potent Injectables Manufacturing Building has a manufacturing area dedicated to DDS-based injectables, where multiple pieces of equipment (GMP-compliant equipment) for manufacturing DDS-based injectables have been introduced. We are capable of manufacturing a wide range of products, from clinical trial drugs to commercial products.

Major Facilities

Particle Sizer	Extruder, Microfluidizer, Microfluidic device
Ultrafiltration Equipment	Available for various ultrafiltration membranes

Non-Hazardous Injectables / Liquids Manufacturing Building

Formulation

Itami Plant Non-Hazardous Injectables / Liquids Manufacturing Building

This is a manufacturing building for injectables and liquids for non-hazardous drugs.
Equipped with an integrated manufacturing line for vials and ampoules for injectables and a manufacturing line for bottled solutions (solutions for inner and external use) for liquids, it is capable of manufacturing highly viscous liquids, such as syrups, and liquids with weak antiseptic properties.
It also has an integrated manufacturing line for filling and packaging jelly formulations and is capable of manufacturing jelly formulations that meet the sterility test requirements.

Major Facilities (Injectables)

Solution Mixing	＜Manufacturing line for vial injectables＞ Solution mixing tank (500 L, 1,200 L, SUS) ＜Manufacturing line for ampule injectables＞ Solution mixing tank (150 L, 250 L, SUS)
Filling	＜Manufacturing line for vial injectables＞ Vial washer sterilizer, Vial filling stoppering machine RABS specification 66 vials/min (φ32.0 mm) ＜Manufacturing line for ampule injectables＞ Ampule washer sterilizer, Fused closure equipment for ampule filling RABS specification 133 ampules/min (1 mL ampule)
Capper	Vial capper Screw capper

Major Facilities (Liquids)

Solution Mixing	＜Manufacturing line for bottled solutions＞ Solution mixing tank (500 L, 2,000 L, SUS) ＜Manufacturing line for jelly formulations＞ Solution mixing tank (2,000 L, SUS) Storage tank (2,000 L, SUS)
Filling	＜Manufacturing line for bottled solutions＞ Bottle washer, Liquid filler, Capper 40 bottles/min (100 mL bottle) ＜Manufacturing line for jelly formulations＞ Tube feeder, Liquid filler 160 tubes/min (30 mL tube)

Manufacturing line for vial injectables

Manufacturing line for ampule injectables

Manufacturing line for bottled solutions

Manufacturing line for jelly formulations

Inspection / Packaging

Injectables can be inspected by automated inspection equipment and mechanically packaged with a labeler and a cartoner.
All products that cannot be inspected by automated inspection equipment are visually inspected by visual inspectors.
All liquids are visually inspected by visual inspectors.
Jelly formulations are processed by serial processing equipment that performs filling and inspection, as well as packaging at a speed of up to 200 bottles per minute.