Combination products, proven before launch.
Kiln is a founder-led development and testing partner for pharmaceutical and biotech teams bringing prefilled syringes, cartridges, autoinjectors and safety devices to market. We help you choose the right primary container, build methods that hold up, and generate the data your design history file needs.
- Primary container selection
- Container closure integrity
- Device design verification
- Engineering fill and assembly
- Tolerance and reliability analysis
A kiln is where materials are put to the test and come out proven. That is the job we do for your drug-device system.
Most combination product programs don't fail on the drug or the device alone. They fail where the two meet: a plunger that glides fine at T0 and sticks at twelve months, a seal that passes on paper and leaks after transit, a spring that can't push a viscous formulation through a thin-wall needle in time. Kiln was built by people who have spent their careers at that interface, and we design every study to find those problems while they can be corrected easily.
Systems we work on
Glass or polymer, single dose or multi-dose, hand-held or on-body. If it holds a drug and delivers to patients, we can develop it.
What we do
Consulting when you need guidance on a key decision, discrete studies when you need an answer to one question, or a complete program from container selection to commercial lot release. Every protocol is written for your system, not pulled off a shelf.
Primary container
The syringe or cartridge is the most critical component in the system. We make sure you pick the right one and understand it completely.
Container selection and characterization
Side-by-side evaluation of candidate syringes, cartridges and plunger stoppers with your formulation. We measure critical dimensions (down to crimp concentricity, septum bulge and air bubble size on cartridges), break-loose and glide forces, and needle shield removal, then track how each candidate changes over time.
Container closure integrity
Leak test methods developed and validated for your specific package. We establish inherent integrity of each seal interface, create calibrated positive controls (laser-drilled glass defects and wire-channel stopper defects), and build a method you can reuse at every stage of the product lifecycle.
Siliconization and particle analysis
Full-surface mapping of silicone oil distribution inside the barrel, measured non-destructively so the same unit can be followed through aging. Paired with sub-visible particle imaging to see what migrates into solution.
Stability and aging programs
Real-time and accelerated aging with scheduled pull points, agitation studies, and functional testing at every timepoint so you can see drift before it becomes a failure.
Plunger stopper comparisons
Head-to-head studies of candidate elastomers or coatings in your syringe with your formulation, following glide force, particles and lubricant behavior across aging timepoints so the choice is made on data.
Graduated and rescue syringe qualification
Design verification and functional stability for graduated syringes: dose and graduation accuracy, graduation line dimensions, needle bond strength, stopper retention and leakage, carried through multi-year aging programs.
Hypodermic syringe compliance
Full annex testing for syringes used by hand or in syringe pumps: lubricant quantity, graduated capacity, dead space, air and liquid leakage past the plunger, and extract testing for acidity, alkalinity and extractable metals.
Device and delivery system
Proving that the finished combination product performs as intended, for every user, after everything shipping can do to it.
Design verification testing
Method development, validation and execution for autoinjectors, pens and needle safety devices, run against the applicable ISO requirements and your design inputs. Protocols, data and reports ready for your design history file.
Autoinjector power pack simulation
Reproduce the force curve of a candidate autoinjector spring and drive your filled syringe with it. Compare device platforms and predict injection time with your formulation before committing to a device.
Distribution and transit simulation
Environmental preconditioning followed by drop, compression, vibration, low-pressure and impact sequences, then full functional and integrity testing on the survivors.
Air shipment and plunger movement
Headspace bubbles expand at altitude and can push a stopper past its sterile boundary. We reproduce cold-chain flight pressure profiles in a vacuum chamber and film stopper position throughout, so you know before your first shipment.
Pen needle and septum performance
Fragmentation and resealability testing of cartridge septa under repeated needle penetration, with filtered and magnified particle identification.
Infusion and wearable delivery
Flow rate, total delivery time and delivered dose for syringe-driven and on-body systems across infusion sets and formulations. Custom fixtures hold the device over a precision balance for the full delivery, and the expelled dose goes on to visible inspection and flow imaging to separate silicone droplets from protein aggregates.
On-body injector adhesion
A wearable only works if it stays on the skin for the full dose. We develop and validate tack, peel and shear methods for the adhesive patch, with fixtures built for your device and a universal test machine, so you can compare adhesives, track performance through aging and support design verification.
On-body container access
Many on-body injectors pierce a cartridge septum or connect to a prefilled syringe at activation. We characterize the force to penetrate the septum with the device's own needle path, so you know the drive system has margin across container and needle tolerances.
Root cause investigations
When injection times drift or a complaint comes in, we characterize the incoming components, track each one through fill, aging and testing, and correlate component variation to device performance, so the investigation ends with a cause rather than a guess.
Reference product benchmarking
For generic and biosimilar programs, we characterize the reference listed product and its container side by side with yours: cartridge and pen dimensions, dose accuracy, forces and leakage, so equivalence is shown with data.
Engineering and method transfer
Some of the most valuable answers come from a set of drawings before a single part is tested. And the best methods are the ones your own team can run.
Tolerance stack-up analysis
Worst-case and statistical stack-ups of barrel, stopper and plunger rod drawings across every supplier combination you are considering, so fit and function problems surface on paper instead of on the line.
Specification development and reliability
We analyze your registration and development data to recommend defensible performance specifications, confirm them with validated testing, and demonstrate reliability at the confidence level your risk file requires.
Burst and stress testing
Burst resistance and destructive mechanical testing across syringe designs, to find margins and compare suppliers under the loads your device will actually apply.
Method transfer, fixtures and training
We develop and validate a method, machine a matched set of fixtures for your lab, and train your analysts on site. Includes device disassembly methods that free the primary container from an autoinjector or safety device for integrity testing, confirmed not to disturb the seals.
Development manufacturing
Representative samples, built to your specifications, so your testing reflects the product you will actually make.
Engineering fill and finish
Small-scale filling of syringes and cartridges with placebo, WFI or drug product. We can fill at nominal and at the low and high process extremes of fill volume and stopper position, with in-process checks at the beginning, middle and end of every run.
Siliconization engineering runs
Need to know how your product behaves at the low and high ends of a supplier's silicone specification? We map the as-received barrels, strip and clean them, re-siliconize to target levels verified by weight and by distribution scan, then package and coordinate sterilization so you get study-ready syringes back.
Device assembly process development
Semi-automated assembly of prefilled syringes into safety devices and autoinjectors, with force and torque monitored on every unit. Fixtures designed to mirror your commercial line, and assembly limits set from data rather than guesswork.
Consulting
Advice from people who have made these decisions before, for the choices that are hardest to undo later.
Container and device selection
Guidance on choosing the primary container and delivery device that fit your formulation, your patients and your supply plan. We help you weigh glass against polymer, prefilled syringe against cartridge, and platform device against custom, and flag the risks of each choice before you commit to a supplier.
Commercialization strategy
Support for the move from clinical supply to commercial launch. We help you plan scale-up, define specifications and incoming inspection, qualify second sources, and build the testing and data package your filing and your production line will depend on.
Industry landscape
A clear view of the combination product market: which container and device suppliers are available, what capacity and lead times look like, where the technology is heading, and how regulatory expectations are shifting. Useful for program planning, investment decisions and partner selection.
How a program runs
We structure work in phases with clear deliverables at each gate, so you always know what you've paid for and what comes next.
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Scope
A working session on your system, your timeline and your regulatory plan. You get a phased proposal with sample requirements and deliverables spelled out.
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Develop
Methods are optimized for your container, fill volume and stopper position using placebo or surrogate wherever possible to save drug product.
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Validate
Multiple test series across operators and days establish precision. You receive the validation protocol, report and a final test method.
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Execute
Design verification, aging timepoints and transit studies run against the validated methods, with data released as each timepoint completes.
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Support
Validated methods stay available for stability pulls, investigations, lot release and complaints, or we transfer them, fixtures included, to your own lab.
Methods index
The test methods we routinely develop and validate. Don't see yours? Ask. Much of our best work starts with a method that didn't exist yet.
| Area | Methods |
|---|---|
| Container closure integrity | High voltage leak detection, helium mass spectrometry leak, headspace gas analysis, vacuum and pressure decay, dye ingress, positive control defect creation, device disassembly for CCI of assembled autoinjectors and safety devices |
| Primary container dimensions | Critical external geometries, barrel inner diameter along length, needle inner and outer diameter, needle length and bend, flange dimensions, plunger geometry, trip edge and eccentricity, plunger position and headspace, graduation line dimensions, cartridge crimp and septum geometry, dead space |
| Primary container mechanics | Break-loose and glide force, needle shield removal, flange breakage, tip and cone breakage, needle penetration force, burst resistance, needle bond strength, plunger stopper detachment |
| Lubrication and particles | Silicone oil distribution mapping, lubricant quantity, silicone weight, barrel stripping and re-siliconization to target levels, sub-visible particle imaging, drug product viscosity and density |
| Device function | Cap removal, activation and override force, injection time and velocity, injection depth, injection force, delivered dose and deliverable volume, click-to-click time, needle shielding and separation force, power pack simulation, graduation and dose-mark accuracy, needle leakage, septum fragmentation and resealability, cartridge and plunger leakage, infusion flow rate |
| On-body injectors | Adhesive tack, peel and shear, septum penetration force at activation, delivered dose and delivery time, visible and subvisible particles in the expelled dose |
| Aging and distribution | Real-time and accelerated aging, agitation, environmental preconditioning, drop, compression, vibration, low pressure and concentrated impact, simulated air shipment with stopper movement capture |
| Syringe extract testing | Acidity and alkalinity limits, extractable metals |
| Engineering analysis | Tolerance stack-up, specification setting from historical data, process capability, reliability demonstration, component-to-performance correlation |
| Manufacturing support | Engineering fill and finish, stopper placement, device assembly with force and torque monitoring, in-process fill weight and stopper height checks, incoming and lot release testing |
Standards we work to
Twenty years where the drug meets the device
Rob Schultheis founded ZebraSci in 2009 and spent more than a decade building it into a combination product testing and inspection company, serving as CEO and later Chief Technology Officer through its acquisition by BD in 2021. Before that, he worked in the biopharmaceutical industry at Amgen.
A mechanical engineer by training, with a BS and MS from Drexel University, Rob has designed automated inspection systems for syringe lubrication and container geometry, and has spoken to industry audiences on container closure integrity testing. Kiln is his next chapter: the same hands-on expertise in a founder-led firm, where the person who scopes your program stays on it.
“I’ve spent my career at the intersection of where the drug meets the device. Kiln exists so that teams find out what their system will do in order to ensure patients are safe.”
Rob Schultheis, Founder
Questions we hear often
If yours isn't here, it's a good thing to bring to a consultation.
When in development should we bring you in?
As early as primary container selection if you can. Choosing a barrel and stopper with data behind it prevents the most expensive surprises later. That said, we regularly join programs mid-stream for design verification, integrity testing or a specific investigation.
Do you work with any syringe, cartridge or device platform?
Yes. We are platform-independent and work with components and devices from any supplier. Fixtures and methods are built around your specific system.
What do you need from us to put together a proposal?
A description of your container and device configuration, the questions you need answered, your timeline, and any design inputs or specifications you already have. We'll tell you exactly what samples and quantities each phase requires.
Can we develop methods with placebo to save drug product?
In most cases, yes. Method development is typically done with placebo or a surrogate solution matched to your formulation's key properties, and drug product is reserved for validation and final testing where it matters.
Once a method is validated, can we keep using it?
That's the point. A validated method becomes an asset for the life of the product: stability pulls, post-transit testing, failure investigations, lot release and complaint handling.
Can you transfer a method to our own lab?
Yes. We can develop and validate a method, build a second set of fixtures for your equipment, and train your team at your site. Many clients use us to get a method right, then run it in-house for routine testing.
Do you support generic and biosimilar programs?
Yes. We benchmark the reference product's container and device against yours, so you have comparative data on dimensions, forces, dose accuracy and integrity.
Can you run our existing methods, or work outside GMP?
Yes to both. We can execute a method you have already validated, and for early engineering questions we can run studies under R&D conditions to get you answers faster and at lower cost. When a study needs to support a filing, it runs under full protocol and report.
What if we need results fast?
Expedited turnaround is available for many studies, with preliminary results shared ahead of the formal report. Tell us your deadline in the consultation request.
How is work priced?
By phase, with deliverables and milestones defined up front. Discrete studies can be quoted on their own; larger programs are broken into gates so you can commit one step at a time.
How do you handle confidentiality?
We're happy to sign your NDA before any technical discussion. We never disclose client names, products or project details.
Book a consultation
Tell us where your program is and what's keeping you up at night. We'll set up a call to talk it through, no obligation.
- Within one business day, we reply to schedule a time that works for you.
- On the call, we'll walk through your system, timeline and open questions. NDA first if you prefer.
- Afterward, you receive a phased proposal with deliverables, sample needs and pricing.
Prefer email? Write to info@kiln-lab.com or call +1 (866) 350-8240.