Bioscience labs

summary

Our Biology Labs fuse bioscience with engineering to speed device innovation - delivering sterility validation, compliance data, and pilot builds that de-risk development.

At OPD, our in-house biology labs are more than a compliance resource - they are an R&D engine that integrates biological testing directly into medical device development. By coupling bioscience expertise with engineering design and prototyping, we help clients explore bold concepts, prove feasibility, and generate regulatory-grade data early in the development cycle. Our labs are supported by a White Room pilot production facility - a dust-free, near-manufacturing environment that bridges the gap between prototype and production. This means we can deliver pilot-scale builds under realistic conditions, giving clients and investors confidence that devices are both clinically and commercially ready.

Services that make it happen

Where bioscience meets design: our Biology Labs accelerate the future of MedTech, turning bold ideas into clinically and commercially ready devices, faster and with confidence

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What our labs enable

Research & Development

Our biology labs unlock early-stage insights for device innovation:

Feasibility studies & assay development across microbiology, molecular, tissue, and cell biology.
Biological validation of device concepts under real-world use conditions.
Material & process optimisation, from coatings and sterilisation to packaging and usability workflows.

Verification & Compliance

We generate regulatory-grade data aligned to ISO 13485, ISO 14971, MDR and device-specific standards:

Cleaning & disinfection validation (ultrasonic, UVC, chemical).
Sterilisation verification with autoclaves and UVC challenge testing.
Packaging and shelf-life validation under simulated storage/transport.
Environmental and operator assessments for real-world assembly conditions.
Usability-related contamination testing to demonstrate patient safety

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Why utilise OPD Biology Labs?

R&D acceleration – Explore feasibility and robustness early, speeding development cycles.

White Room bridge – Pilot builds under production-like conditions, reducing premature tech transfer.

Cross-sector relevance – Supporting surgical, diagnostic, and digital health innovation.

Regulatory credibility – Generate trusted data packages aligned with ISO and MDR standards.

End-to-end integration – Combine microbiology with OPD’s engineering, usability, and prototyping expertise

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Bioscience - Sector applications

Our labs support innovation across all OPD’s medical device sectors:

Clinical & Surgical Devices

Test cleaning cycles for reusable instruments.
Validate sterile barrier packaging and microbial ingress resistance.
Study microbial adhesion to implantable materials.
Simulate surgical workflows with biosafety controls.
Lab equipment verification and validation

Diagnostics, Imaging & Cell/Gene Therapies

Run microbial challenge tests on cartridges and POC systems.
Assess fluidic stability and cross-contamination in microfluidics.
Verify sterility in consumables and diagnostic transport systems.
Support aseptic handling and packaging for advanced therapies.

Digital Health Tech

Evaluate microbial survival on skin or oral-contact wearables.
Simulate home-use and remote monitoring workflows for hygiene risks.
Integrate biological testing into usability studies for connected devices.

By embedding bioscience directly into product development, OPD removes the delays and risks of outsourcing. Our clients benefit from faster iteration, stronger data, and smoother regulatory journeys - taking devices from concept through verification with greater efficiency and confidence.

Equipment

Our Equipment & Capabilities

Our +300 sq ft containment level 2 (CL2) Biology Labs are equipped to handle molecular biology, microbiology, tissue studies, and device verification. This means we can generate data that is both scientifically robust and commercially relevant.

Core Capabilities

01
Biology (Wet) Lab
Fully equipped CL2 certified, supporting microbial research for sterility validation and contamination control across all device sectors.
02
Dry Lab
A versatile laboratory area that provides additional lab space when extra capacity is needed for experiments. Suitable for molecular biology, tissue work, assay prep, and engineering-biological integration studies.
03
White Room Facility
Controlled, dust-free build environment with filtered air circulation for prototypes and pilot-scale production. Supports manufacturing-realistic verification for all device types.
The White Room acts as a manufacturing bridge. It enables prototypes and pilot builds that emulate production conditions, supporting verification and validation before devices are deployed in the field. This reduces the need for premature technology transfer, accelerates iteration, and provides critical data for regulatory and investor confidence.
04
Sterility & Contamination Control
- Laminar flow hoods (CL2 biosafety cabinets) for aseptic workflows
- Autoclaves, UVC chambers, and ultrasonic baths for sterilisation and cleaning validation.
05
Biological Testing & Validation
- Incubators (aerobic/anaerobic) for microbial and tissue studies.
- Colony counters, plate readers, and spectrophotometers for quantitative microbial and molecular assays.
- Microscopy for cell/tissue interaction and microbial morphology studies.
06
Packaging & Shelf-Life Studies
- Climate chamber to simulate storage, transport, and environmental stresses.
- Heat seal machines for sterile barrier validation.
- Environmental monitoring tools (particle counters, surface swabs, settle plates).
07
Prototype & Pilot Build Support
- White Room facility for dust-free, near-production builds.
- Fluid dispensing robot for automated workflows.
- Digital die-cutting machine for membranes, labels, and device components.
- Plasma treatment system to improve material bonding and biocompatibility.
08
General Lab Infrastructure
- Cold storage fridges & freezers at both 4°C & -20°Cfor sensitive samples.
- Centrifuges for sample preparation.
- Precision heating and mixing equipment (hotplates, stirrers, controllers).

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Bioscience labs

Services that make it happen

Core Capabilities

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