Sharp’s Heerenveen facility provides both large-scale and specialised small-batch packaging capacity in shared or dedicated production suites. We offer expertise and capabilities in multiple specialist formats, and enables access to the EU market through in-house QP services.
Our facility also offers a complete range of specialized cold chain packaging and labelling services for gene therapy products. A specialist infrastructure is in place including temperature and humidity controls and monitoring, and full -80°C freezer banks in shared or dedicated packaging suites.
Sharp Heerenveen holds also a European clinical services depot offering distribution and QP release services for investigational medicinal products (IMPs) in conjunction with our site in Rhymney, UK.
Facility Highlights
- 8,500 m2 (92,100 ft2) facility including GMP production space, warehouse and offices
- Ambient and refrigerated (2-8°C) packaging, storage, and distribution
- Frozen (-80°C) storage and distribution
- Shared and dedicated production areas
- Controlled drug management
- Manufacturing License for Wholesale Distribution Authorisation (WDA) and Investigational Medicinal Product (IMP)
- Electronic Batch Record (EBR) generated via our Manufacturing Execution Systems (MES)
- Gene therapy small-batch cold chain packaging suite
- Optimal environment and specialist infrastructure
- Dedicated HVAC air handling
- Temperature and humidity controls and monitoring
- Full -80°C freezer banks in dedicated production suites
Contract Services
Secondary packaging
- Gene therapy vial labelling and packaging
- Bottle labelling and packaging
- Autoinjector and pen assembly, labelling and packaging
- Ampoule and blow-fill-seal (BFS) container pouching and packaging
- Cartoning, multi-component kitting and rework
- Package design
- Serialisation and aggregation
- EU QP release to market services
- Clinical depot, including distribution and QP services
Quality Accreditation
- Regulated by Dutch Health and Youth Care Inspectorate (IGJ)
- Ministry of Health of the Republic of Belarus – inspected
- Ministry of Industry and Trade of the Russian Federation – inspected
- Manufacturing License 108630F WDA 16273G
- GMP certified
Contact
Neptunus 12
8448 CN Heerenveen
The Netherlands
Tel: +31 513 433 947
info@sharpservices.com