specialists in automated systems

Special Purpose Machines

- Design & Build- Validation- Integration- Consultancy- Distribution

From bench-top equipment...

...to full-scale production

25 Years Experience

Bespoke Automation

Reagent Deposition-Slot coating

(Image removed for confidentiality)

Deposition – Contact Plotting

Deposition - Spraying Equipment

Droplet Formation- Microlitre - Nanolitre - Picolitre

-

Distribution ~Microdispensing Technology

• Micro-dispensing – Nanotechnology Applications

• Patented Deposition Method• OEM & Workstations

- Marking & Ablation

- Cutting and Welding

- Laser Safety

- Fume Extraction

Laser Integration – YAG - Diode - CO2

Laser Transmission Welding of PolymersDistribution

Test Strip Lamination

Vision Systems

- Quality Control

- Pick and Place

- Line & Area Scan

- Measurement

- Customised Screens

Vision Systems

In-house Control Software

• PC or PLC• Full integration• Software validation• Windows-based user interfaces

where appropriate

Software Validation Support

- 21CFR11

- GAMP5

- Audit trail

- Electronic records

- FMEA & risk assessments

A few examples...

Proof of Principle / Hand Assembly

Deposition of Reagent into liquid nitrogenDeposition of Reagent into liquid nitrogen

Alignment of Adhesives into a Medical Device

Alignment and lamination of adhesive layer onto band - medical device

Integration of standard label applicator - medical device pilot line

Accurate punching of alignment holes in thin film layer

Complex Component Assembly

- Reel Fed Substrate- Laser Safety

Laser Integration

- Laser Integration- Microfluidic Device

Metered Dose Inhalers

- Shaking- Drug Collection- Waste Shots

- Major Customer- Validated Systems- Used World-Wide

- Diabetes Test Strip Lamination- SCARA Robot with Integrated cameras

- Test Kit Manufacture- Inkjet Printing

- Detailed Vision Analysis- Error Marking

- Pick & Place of Ø600µm contact for biosensor- Accurate Pick & Place ±5µm

- Card Handling- Mesh Feed

- Ultrasonic Welding Station- Cleanroom Class 100,000

- Automatic Biosensor Testing - Current Measurement 0-10µA ±2µA

- Log of Calibration Data- 21CFR11 Compliance

Feed Nitrocellulose SheetCrop & Punch To Create Band Format

Band AlignmentAntibody Plotting and Vision Line Scan Inspection

Band AlignmentBlocking, Stabilising and Inspection

Band Drying – hot air systemAfter plotting at 75 deg CAfter Blocking & Stabilising at 55 deg C

Error Marking – Strip by StripBand Stacking – Good, Reject & QC stacks

Complete System

PLANNING & DEFINITIONPROCESS VALIDATION PLAN

PROCESS RISK ASSESSMENT

DESIGN SPECIFICATIONS & DEVELOPMENT

FUNCTIONAL SPECIFICATION (FS)(traced from URS)

ACCEPTANCE TEST PROTOCOL (FAT)(traced from QPP, FS

and HDS /SDS for high risk items)

HARDWARE DESIGN SPECIFICATION (HDS)(traced from FS)

SOFTWARE DESIGN SPECIFICATION (SDS)(traced from FS)

DRAWING PACKAGE FOR HARDWARE

PREPARATION OF SYSTEM INSTALLATION PLAN DOCUMENT (SIP)

MANUFACTURE BESPOKE HARDWARE ITEMS

ASSEMBLE MACHINE

CONFIGURE / CODE BESPOKE SOFTWARE ITEMS

CODE REVIEWS AND STRUCTURAL TESTING (depth depends on risk assessment)

SYSTEM BUILD

DEVELOPMENT TESTING

SYSTEM INTEGRATIONINTEGRATE SOFTWARE WITH HARDWARE

INTERNAL TESTING AGAINST FAT PROTOCOL

ACCEPTANCE TESTINGCUSTOMER WITNESSED FACTORY ACCEPTANCE TESTING

(FAT)

PREPARATION OFIQ/OQ/PQ PROTOCOLS

COMMISSIONING & QUALIFICATION

SYSTEM INSTALLATION AND COMMISSIONING TO SIP

INSTALLATION QUALIFICATION FOR PROCESS (IQ), OPERATIONAL QUALIFICATION FOR PROCESS (OQ),PERFORMANCE QUALIFICATION FOR PROCESS (PQ)

HARDWARE BUILD QUALITY TESTING

PREPARATION OF TECHNICAL CONSTRUCTION FILE (TCF)

SHIPMENT OF SYSTEM

USER REQUIREMENT SPECIFICATION (URS)

QUALITY & PROJECT PLAN (QPP)(traced from URS)

Design and Risk Assessment Review

Design and Risk Assessment Review

PROTOTYPING OF COMPLEX INTERFACES AND FUNCTIONS

PROOF OF CONCEPT STUDIES

SOFTWARE BUILD QUALITY TESTING

PURCHASE STANDARD HARDWARE AND SOFTWARE ITEMS

COMPILE / BUILD SOFTWARE

VALIDATION REPORT

CUSTOMER RESPONSIBILITY

HORIZON RESPONSIBILITY

SHARED RESPONSIBILITY

Design and Risk Assessment Review Design and Risk Assessment Review

CONFIGURATION MANAGEMENT SPECIFICATION (CMS)

Example of Lifecycle

Quality Management

• ISO 9001: 2000 accreditation

• All work carried out follows strict procedures

Summary of ServicesMechanical DesignElectrical DesignSoftware CodingMachine ShopAssemblyTest ValidationDocumentationDistribution partnershipsAfter Sales Support

Customers served:3M Abbott AstraZeneca British Biocell International Cambridge UniversityCarclo Technical Plastics Cozart BiosciencesDiagnostics for the Real World Eastman Biochemical Genesis Diagnostics Genosis GlaxoSmithKline HypoguardInverness Medical Innovations Ivax Pharmaceuticals

L3 TechnologyLifeScan Scotland – (a Johnson & Johnson company) MediSense Oxoid Phadia Porvair Sciences Provalis Diagnostics Randox Laboratories Scandinavian Micro Biodevices Stirling Medical Innovations Trinity Biotech UnipathVerax BiomedicalVivacta

specialists in automated systems