OUR FACILITIES

DEC
Healthcare

At DEC Healthcare our technical teams specialise in the research, development, manufacturing and commercialisation of innovative technologies and pharmaceutical solutions for human and animal health.
With continuous investment in research and development, our people and technologies consistently deliver the highest quality products and services to our customers, and currently reach over 50 international markets.
This facility is one of NZ’s only U.S. FDA-approved GMP facilities. Experts in controlled / controlled-release drug technology.

OUR FACILITIES

DEC
Healthcare

At DEC Healthcare our technical teams specialise in the research, development, manufacturing and commercialisation of innovative technologies and pharmaceutical solutions for human and animal health.
With continuous investment in research and development, our people and technologies consistently deliver the highest quality products and services to our customers, and currently reach over 50 international markets.
This facility is one of NZ’s only U.S. FDA-approved GMP facilities. Experts in controlled / controlled-release drug technology.

Capabilities

Our in-house GMP facility undertakes testing of incoming goods and final product testing including release profiles. We undertake batch testing on site, which allows us to create a GMP standard for export to regulated international markets.

We have the capacity to store our own supply chain in temperature-controlled warehousing. Our Pharmaceutical facility outputs nine million controlled-release devices per year, exporting to over 50 international markets.

TEAMS

Product Development
From prototype to design freezes for in vivo trials

Process Development
Scalable, cost driven manufacturing process design and testing

Analytical Development
CMC strategy for your product
Chemistry, mechanical, and material testing of raw materials, in-process monitoring, and release testing

Design for Manufacture
Component design for scalable, cost-driven manufacture

Tooling/Engineering
Delivery of quality tooling to manufacture your product at scale

Manufacture
Manufacture at any scale with manufacture/assembly rooms that can be used for both flexible/small-scale batches, and fixed plant large-scale continuous product

Quality Assurance
Quality documentation to ensure your product is compliance, and delivered to specification
Support in your Technical File submission for product registrations

Quality Control
Testing of raw materials, in-process samples, and finished product to ensure quality end-to-end.

FACILITIES

R&D
Development and tech-transfer of your innovation into DEC, as we prepare it for GMP, or ISO 13485 manufacture

Scalable manufacture
Injection moulding/overmoulding
Compression moulding
Casting
Extrusion
Mixing and dispensing
Labelling and packaging

Assembly
Component assembly
Electronic assembly (anti-static)

Testing
Spectral analyses (HPLC/UPLC, UV-Vis, FTIR)
Dissolution
DSC (Differential Scanning Calorimetry)
Mechanical testing
Microscopy
Solvent chemistry (soxhlet)

Accreditation

DEC Pharmaceutical has achieved FDA approval into the highly regulated US health market, and equivalent registrations (like MedSafe or TGA), assembling to ISO-13485 in our GMP facility.

We use our GMP capabilities to develop and manufacture Controlled Drug Release devices and other human and animal health products. Our products have received FDA certification, and as such, our product and process quality levels are routinely audited to ensure they are among the best globally.

Our manufacturing standards are measured and maintained by a commitment to industry benchmarks: DIFOT (three-year consistent level: 100%); manufacturing to plan (constant at 100%); Right First Time measures; among others.

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