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DK-04 · Device Assembly Systems
Diagnostic Device Automation
Automated assembly and inspection for diagnostic devices with a record for every unit
Overview
What This Machine Does
Diagnostic devices carry two demands at once: a build that is consistent enough to trust, and evidence that each unit was built that way. Automation is how both are achieved at production volume.
Delkotech builds assembly and inspection equipment for this class of product, designed to operate in mass production and to be validated to current regulatory standards. Process values are recorded per unit and tied to the unit identifier, so the record follows the device rather than the shift.
Handling is designed for the contamination and consistency requirements the device carries, with materials and access chosen accordingly rather than assumed from general industrial practice.
From the original specification: Diagnostic device automation is listed among Delkotech's services.
Key Benefits
What It Changes on Your Floor
Consistency at volume
The process holds across the batch rather than drifting with the operator or the hour.
Record tied to the unit
Process values follow the device identifier, so a later question about one unit has an answer.
Inspection in the build
Checks sit inside the sequence, so a failure is caught before more value is added.
Designed for validation
Built to be validated to current regulatory standards and supplied with documentation that supports it.
Contamination considered
Materials, access and airflow chosen for the device rather than inherited from general industrial design.
Application Scenarios
Where It Is Used
Diagnostic consumable assembly
Assembling components at a controlled rate with in line verification.
Automated inspection
Confirming dimensional or functional characteristics on every unit.
Controlled dispensing and filling
Placing a metered quantity at a controlled position.
Serialisation and traceability
Tying the process record to the unit identifier.
Who It Is For
Plants That Ask for This Machine
- Diagnostic device manufacturers scaling from manual to automated production
- Producers who must show a record per unit rather than per batch
- Plants whose yield loss appears at final inspection with no upstream data
- Quality groups who need equipment documentation that supports validation
Problems It Solves
Manual process drift
Hand assembly of a device with tight process windows drifts, and the drift is only visible in the yield.
Batch level records
When something is wrong with one unit, a batch record does not narrow it down.
Late inspection
Inspecting at the end means paying for every operation on a unit that was already failing.
Equipment that cannot be validated
Undocumented machines create findings that engineering then has to solve retrospectively.
Technical Features
How It Is Built
Controlled assembly stations
Each operation with defined parameters and in cycle verification.
Automated inspection
Dimensional or functional checking on every unit.
Per unit traceability
Process values tied to the unit identifier throughout the machine.
Reject separation
Failed units separated automatically into a controlled location.
Contamination aware design
Material selection, surface finish and access designed for the product requirement.
Validation ready documentation
Sequence of operation, as built drawings and test records supplied.
Specifications
Specification Sheet
Delkotech builds to order, so dimensional and performance values are set against your part at design review, then measured and recorded before shipment. Values not yet fixed for your project are marked TBC rather than guessed.
| System type | Automated diagnostic device assembly and inspection system |
|---|---|
| Station count | Specified per device and rate |
| Inspection | Per unit, integrated into the build sequence |
| Traceability | Process values tied to the unit identifier |
| Reject handling | Automatic separation into a controlled location |
| Cycle time | TBC - confirmed at design review |
| Throughput | TBC - confirmed at design review |
| Inspection parameters | TBC - confirmed at design review |
| Footprint | TBC - confirmed at design review |
| Control platform | PLC with HMI, platform agreed with the customer |
| Data output | Per unit record available to quality systems |
| Validation | Designed to be validated to current regulatory standards |
| Environmental requirements | Specified with the customer, TBC until confirmed |
| Built at | Delkotech facility, Vaughan, Ontario, Canada |
| Contact surfaces | Materials and surface finishes selected for the product contamination requirement |
|---|---|
| Structure | Welded and machined steel with finishes suited to the production environment |
| Tooling | Part specific nests and tooling designed for gentle, repeatable handling |
| Handles | Diagnostic devices, consumables and their components as specified |
Manufacturing Process
From Enquiry to Commissioned Machine
Device and process study
Assembly steps, critical parameters and inspection requirements reviewed with real samples.
Sequence of operation
Written and agreed before design proceeds.
Design
Stations, handling, inspection, controls and environment designed together.
Build
Manufactured and assembled at the Vaughan facility.
Capability and failure mode proving
Repeatability measured and failure detection proved with known bad units.
Installation and validation support
Installed and supported through your validation protocols.
Quality Control
What Is Checked Before It Ships
- Critical process parameters measured and recorded across the operating range
- Inspection proved against known good and known bad units
- Traceability record checked end to end for a full batch
- Continuous run to confirm stability at rate
- Documentation package reviewed against the written sequence of operation
Certifications
Compliance Position
Equipment is designed to be validated to current regulatory standards and is supplied with documentation supporting validation. Delkotech does not certify the customer's device or its regulatory status. Environmental classifications and project specific certificates are agreed at contract stage and listed as TBC until confirmed.
Customization Options
- Station count and rate set to your volume
- Inspection method chosen for the characteristic that matters
- Traceability structure matched to your identifier scheme
- Environmental controls specified for the device
- Data output to your quality systems
- Support through your validation protocols
Comparison
Compared With the Alternatives
| Manual assembly with final inspection | Flexible at low volume, but process drift is invisible until yield falls and records are batch level. |
|---|---|
| Automation without integrated inspection | Delivers consistency but not evidence. For a diagnostic device the evidence is usually the requirement. |
| Standard assembly platform | Lower capital cost when the device fits it. The adaptation and the validation gap usually cost more than the saving. |
Use Guide
Running It Well
Run reference units regularly
Known good and known bad units confirm the inspection is still discriminating, which a pass rate alone does not.
Keep the documentation current
Approved changes belong in the sequence of operation, because that is the document validation references.
Do not relax a check to clear a backlog
An inspection that is rejecting units is reporting a process problem worth finding.
Control access to parameters
Process parameters should be change controlled at the HMI, not adjustable by anyone on shift.
Questions
Diagnostic Device Automation Questions
Can the system produce a record for every unit?
Yes, where the device carries an identifier. Process values and inspection results are tied to that identifier and made available to your quality systems.
Will the equipment support our validation?
It is designed to be validated to current regulatory standards and is supplied with the sequence of operation, as built drawings and test records. The validation itself is executed with your quality group against your protocols.
Do you build to a cleanroom classification?
Environmental requirements are specified with you. If a classified environment is required, it is agreed at contract stage and reflected in the material and design choices.
How do you prove the inspection works?
With known bad units. Passing good units demonstrates very little on its own, so failure detection is proved deliberately and recorded during build.
What happens to rejected units?
They are separated automatically into a controlled location so they cannot re-enter the flow.
What should we send to start a discussion?
Device drawings, real samples including failure examples, your critical process parameters and your volume.
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