Diagnostics Consumables Manufacturing | Precision Filling
Diagnostics consumables manufacturing with precision reagent filling and lab-on-chip blister systems. From pilot to high-volume production.
Reagent Filling and Microfluidic Blister Systems Structured for Scale
Diagnostics manufacturing shifts at scale.
What performs in pilot runs must maintain precision at commercial volume. Reagent stability, fill accuracy, and cartridge performance must remain consistent as production increases.
Through the integration of J-Pac Medical, LSO supports diagnostics consumables manufacturing with expertise in lab-on-chip reagent blisters, precision filling, and microfluidic cartridge integration.
Lab-on-Chip Reagent Blister Expertise
As diagnostic tests move closer to the point-of-care, reagent storage and delivery become design challenges
LSO’s East Coast location (formerly J-Pac Medical) has developed reagent blister reservoirs that allow reagents to be stored directly on the microfluidic test cartridge
Capabilities include:
- Burst and frangible seal blister designs
- Custom activation mechanisms
- Multiple chemistries and volume configurations
- Sample and development kits for early-stage programs
- Blister fluid volumes ranging from 30µl to 1,000µl
Precision Filling and Reagent Integrity
Fill accuracy directly influences assay performance.
LSO supports controlled reagent filling within regulated environments structured to maintain:
- Volume precision
- Repeatability across production lots
- Controlled environmental conditions
- Process documentation aligned with ISO 13485
Additionally, “No Head Space” technology supports low-oxygen reagent storage for sensitive chemistries.
Production workflows are structured to maintain consistency as programs scale from pilot volumes to high-volume manufacturing.
Design for Manufacture (DFM) for Diagnostics
Scaling diagnostics consumables requires coordination between:
- Polymer forming processes
- Cartridge geometry
- Activation mechanisms
- Filling parameters
- Packaging integration
LSO’s diagnostics engineering teams support both blister development and manufacturing in a one-stop model.
Early engagement supports smoother transition from:
- Samples
- Pilot runs
- Initial launch
- High-volume production.
Engineering collaboration reduces redesign risk and yield instability at scale.
Structured for Volume Growth and Supply Continuity
Diagnostics programs often transition rapidly from development to sustained production.
LSO supports:
- Controlled cleanroom environments
- Precision consumable assembly
- Integrated packaging
- Quality documentation and traceability
- Supply continuity planning
Diagnostics manufacturing operates within LSO’s broader ISO 13485-certified and FDA-registered infrastructure.
Frequently Asked Questions
Does LSO support lab-on-chip reagent blisters?
Yes. LSO’s East Coast location (formerly J-Pac Medical) manufactures reagent blister reservoirs designed for microfluidic test cards.
Can LSO support pilot through commercial production?
Yes. Production supports samples and pilot runs through high-volume manufacturing.
Are multiple reagent volumes supported?
Yes. Blister volumes range from 30µl to 1,000µl depending on configuration.
Is manufacturing conducted within a regulated quality system?
Yes. LSO operates within FDA-registered facilities under an ISO 13485-certified quality system.
Does LSO support lab-on-chip reagent blisters?
Yes. LSO’s East Coast location (formerly J-Pac Medical) manufactures reagent blister reservoirs designed for microfluidic test cards.
Can LSO support pilot through commercial production?
Yes. Production supports samples and pilot runs through high-volume manufacturing.
Are multiple reagent volumes supported?
Yes. Blister volumes range from 30µl to 1,000µl depending on configuration.
Is manufacturing conducted within a regulated quality system?
Yes. LSO operates within FDA-registered facilities under an ISO 13485-certified quality system.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
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