- One-stop support from manufacturing to shipment,
including packaging and sterilization coordination - Pre-sterilization primary packaging support
and coordination with qualified sterilization service providers - Manufacturing, assembly, inspection, and packaging
services within a controlled cleanroom environment
Nissha provides integrated contract manufacturing services from manufacturing to shipment, including packaging and sterilization coordination. We procure customer-specified radiation-resistant and sterile packaging materials, containers, and pouches, and support pre-sterilization primary packaging in coordination with sterilization service providers.
Partial services are also available, including assembly-only or packaging-only support.
Providing comprehensive contract services from manufacturing to shipment
Services provided in a controlled cleanroom environment
Contract Sterile Packaging Services
- Procurement of sterile packaging materials
- Primary packaging prior to sterilization
- Repackaging and individual packaging of bulk products
- Kitting, product combination, and packaging
- Operations conducted in a cleanroom environment
- Packaging validation
- Final inspection and shipment
Note: These services are provided as part of medical device manufacturing and are not available for direct requests from hospitals, clinics, or other healthcare facilities.
6000m² of Cleanroom Facilities in Japan
Nissha operates ISO Class 7 (Class 10,000) cleanrooms across multiple sites in Japan, including a 1,000m² cleanroom at our Kyoto headquarters with an additional 5,000㎡ expansion area.
Leveraging extensive cleanroom expertise, we support medical device manufacturing, assembly, inspection, and packaging, including highly regulated devices requiring stringent quality control.
Quality management system based on ISO 13485 and the Japan’s QMS Ordinance
ISO 13485 certification is increasingly required in global markets. Nissha is certified to ISO 13485:2016 at our global headquarters in Kyoto and maintains a quality management system aligned with Japan’s QMS Ordinance, which sets requirements for medical device manufacturing and quality control.
