With a history spanning over 60 years, our EU Injectables Centre of Excellence specialises in the assembly, labelling and secondary packaging of injectables.
Sharp Belgium has a particular expertise in engineering, technology, project management and package design offering solutions that support the demands of complex packaging for vials, pre-filled syringe (PFS), autoinjector and pen presentations with cold storage requirements.
Our GMP facility specialises in managing complex SKUs & product portfolios and late-stage customisation. This means bulk product can be staged as close to market as possible, prior to being rapidly custom packaged for each specific market.
Facility Highlights
- 16,181 m2 (174,000 ft2) facility including GMP production space, warehouse and offices
- Segregated suites and HVAC systems
- Ambient and refrigerated (2-8°C) packaging, storage and distribution
- Shared and dedicated production areas
- Manual, semi-automatic or fully automated equipment
- Global market support
Contract Services
Secondary packaging
- Vial labelling and packaging
- Assembly, labelling and packaging of:
- Pre-filled syringe and safety syringe devices
- Pens and autoinjectors
- Medical devices
- Cartoning, multi-component kitting and rework
- Customised product packaging
- Package design
- Serialization and aggregation
- QP release to market services
Quality Accreditation
- Licensed by Belgian Health Authority (FAHMP) – GMP certified
- 587 H – Human Medicinal Products (certificate number: BE/GMP/2018/026)
- 587 IMP – Investigational Medicinal Products (certificate number: BE/GMP/2018/025)
- LRQA Certified ISO 13485:2016
- FDA Registered & Inspected
- Brazilian Health Regulatory Agency (ANVISA) Registered & Inspected
- GMP Certified by the Russian Federation
Accommodation Nearby
Contact
Klöcknerstraat 1
B-3930 Hamont-Achel
Belgium
Tel: +32 (0)11440111
info@sharpservices.com
