Industries / Pharma & Medical
Molded Fiber Packaging for Pharma & Medical
We will tell you where fiber belongs in a medical pack — and where it does not. Fiber is normally applied to the secondary and tertiary layers around the sterile barrier, not to the barrier itself. Starting from that boundary is what makes the rest of the conversation useful.
The Boundary Comes First, Then the Engineering
In most sectors the packaging discussion starts with the product. Here it starts with which layer of the pack is being discussed, because the answer changes everything that follows.
A medical pack is a system of layers. The sterile barrier system is the layer that maintains sterility, and it is governed by a defined material route, a validated sealing process and a qualification programme of its own. Around it sit the secondary layer that positions and protects, and the tertiary layer that survives distribution. Molded fiber is applied to the second and third of these. It is not a sterile barrier material, and THECA does not present it as one.
Once that boundary is fixed, the engineering questions become concrete and answerable. A positioning tray for vials or syringes is judged on whether each unit stays exactly where it was placed through handling, transport and inspection, because positional drift is what causes breakage, mis-picks and rejected batches. A kit tray is judged on whether the assembly sequence is unambiguous, so a component cannot be missed or placed wrong. Both are judged on particulate behaviour, on whether the format can be documented batch by batch, and on whether a customer's quality function can audit how it was made.
These are not marketing questions. They are the ones a supplier qualification process actually asks, and a packaging project in this sector stalls when they are answered late. THECA works from the boundary outwards and confirms each requirement against the specific application before any geometry is proposed.
Applications in Pharma & Medical
Every format below sits outside the sterile barrier. Where a project needs the barrier itself, that belongs to a different material route and we will say so.
Vial, ampoule and syringe positioning trays
Glass primary containers fail on contact and on shock transmitted through the pack. The tray holds each unit in a defined position with a controlled contact area, so units cannot touch each other or migrate during handling and transport. Cavity tolerances are developed against the real container dimensions including their manufacturing variation, and the tray's own stacking behaviour is specified so that load reaching a lower layer does not reach the containers inside it.
Molded pulp medical productsDevice and kit organisation trays
Where a pack contains several components assembled in sequence, the tray is partly a protective component and partly a work instruction. Cavity shape, depth and separation make the intended assembly order legible and make an omission visible before the pack is closed. This is developed against the actual assembly process and the people carrying it out, not against a drawing of the finished kit.
Molded pulp medical productsClinical and sample transport inserts
Sample and clinical logistics move small, fragile, individually valuable items through a distribution chain that is not always gentle. The insert restrains each item, keeps identification visible where required and survives the handling profile the route presents. Where the route involves temperature control, the format is assessed under those conditions rather than at ambient.
Custom molded fiber packagingSecondary trays and layer formats for distribution
Outside the individual pack, cartons of product move on pallets and stand in warehouses. Secondary trays and layer formats control stacking, prevent migration within the case and keep the pack-out dimensionally predictable. These are conventional transport engineering problems, and they are where fiber replaces the largest volume of incumbent plastic in this sector.
Pulp wrap packagingDenesting-optimised formats for validated lines
Where the pack station is automated or semi-automated, geometry is specification. Denesting reliability, gripper contact zones, orientation features and part-to-part consistency determine whether a format can be run at all in a line that has been validated around a previous component. These parameters are reviewed against the actual equipment and confirmed through trials with production-representative samples.
THECA technology and product developmentEngineering Priorities, in This Sector's Order
In pharma and medical, documentation sits higher than it does anywhere else on this site, and the boundary question sits above everything.
Which layer of the pack is being specified
The first question is whether the component sits inside or outside the sterile barrier system. Molded fiber is applied to the secondary and tertiary layers. Where a brief asks fiber to perform a sterile barrier function, or to sit inside a validated barrier system, we say so at the first review rather than after tooling has been discussed. Establishing this boundary in week one is the single most useful thing that happens in a medical packaging project.
Positional accuracy and retention
Positional drift causes glass-to-glass contact, breakage, mis-picks and inspection failures. Cavity geometry is developed against the real container dimensions and their manufacturing variation, and retention is assessed under the handling and transport the pack actually meets — not only at rest. Where an automated line places or removes units, retention force is reviewed against the equipment so the tray holds during transport but releases predictably in operation.
Particulate and cleanliness behaviour
Fiber components generate and shed particulate to a degree that depends on the material route, the forming process and any finishing step. Where cleanliness is a controlling requirement, the acceptable level, the method of assessment and the production and handling conditions are agreed per project against the customer's own standard. THECA does not publish a general cleanliness class for molded fiber, because a figure without a stated method and application is not usable evidence.
Traceability and batch documentation
In this sector the packaging component carries a documentation obligation as well as a protective one. Batch identification, material route records, inspection points and change control are defined at the specification stage so that each delivery can be traced back and any change is visible to your quality function. What is documented, in what format and with what retention period is agreed before series production rather than assembled retrospectively.
Stacking and transport under the validated profile
Once the first four are settled, the conventional transport engineering applies: compression through the stack, drop and handling, and behaviour under the humidity and temperature the distribution route presents. The difference here is that the acceptance criteria usually come from a validated distribution profile the customer already holds, so testing is aligned to that profile rather than to a generic standard.
Which Format Fits Which Medical Application
Note the layer column. Nothing in this table is a sterile barrier component.
| Format | Packaging layer | Best for | Typical protection function | Validation focus |
|---|---|---|---|---|
| Positioning trays | Secondary | Vials, ampoules, syringes and other glass primary containers | Individual restraint with controlled contact; no unit-to-unit contact | Fit accuracy, retention under transport, particulate, stacking |
| Kit and device trays | Secondary | Multi-component kits assembled in a defined sequence | Position, separation and legible assembly order | Assembly ergonomics, retention, cleanliness, denesting |
| Clinical transport inserts | Secondary or tertiary | Sample and clinical logistics | Restraint and shock isolation through an uncontrolled route | Drop and handling, conditioned performance, identification access |
| Secondary trays and layer formats | Tertiary | Case and pallet movement of finished packs | Stack control and migration prevention within the case | Compression over duration, cartonisation efficiency |
| Denesting-optimised formats | Secondary | Automated and semi-automated validated lines | Reliable single-part separation at line speed | Denesting repeatability, part consistency, gripper compatibility |
Material suitability, tolerances, coatings and any performance or compliance claim are confirmed per project against the specific application, market and supporting test evidence. Layer allocation shown here is typical and is confirmed against your own packaging system.
The Compliance Layer for Medical Packaging
The EU Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40) has applied across all member states since 12 August 2026 and covers packaging as placed on the market, including medical and pharmaceutical packaging. Minimisation, conformity documentation and substance restrictions apply now, with recyclability design requirements, recycled content thresholds and the empty-space ratio limit scheduled for 1 January 2030.
In this sector a second and more demanding layer applies, and it operates on the packaging system rather than on the component.
What ISO 13485 does and does not cover
THECA holds an ISO 13485:2016 certificate for a medical-sector quality management system, covering the production and sales activities stated in the certificate scope. That certificate covers the management system. It does not certify an individual product as a medical device, as sterile, as suitable for use as a sterile barrier, as approved for direct patient contact, or as compliant with every medical-device regulatory requirement. Product classification, intended use, sterile-barrier requirements and application-specific validation remain separate matters, and they sit with the manufacturer placing the device on the market.
Supplier qualification and documentation
In practice, the requirement that governs a medical packaging project is the customer's own supplier qualification process: specification control, change notification, batch traceability, inspection records and the right to audit. These expectations are agreed at the specification stage and built into how the component is produced and documented, rather than assembled after the first delivery. Where your quality function needs a specific record or a defined change-control route, that is a design input like any other.
Sterilisation is a separate question again. Whether a packaging component is exposed to a sterilisation process, which process, and what that does to its properties and to any documentation it carries, is assessed for the specific component and the specific process. It is not assumed from the material.
THECA limits every regulatory, recyclability, compostability and certification statement to the specific material, application, market and supporting evidence it actually covers. Relevant certificates and analysis reports are available for review.
What Fiber Replaces Here, and What It Costs You
In this sector the incumbent is usually a precisely dimensioned plastic component inside a qualified system. Changing it is a documentation exercise as much as an engineering one.
The standard incumbent for vial and syringe positioning. They hold tighter tolerances than fiber and they are transparent, which some inspection steps rely on. Where the tray is doing restraint and protection rather than enabling visual inspection, fiber competes well. Where visibility is a genuine process requirement, say so early — it usually decides the answer.
Common in device and instrument packs. Foam conforms to irregular shapes without tooling, which fiber cannot match at low volume. Fiber wins on nesting efficiency, dimensional repeatability and mono-material simplicity, and it removes a component that is difficult to recycle. The volume threshold matters here more than in most sectors, because medical batch sizes vary widely.
Where the box is providing thermal performance, fiber is not a like-for-like replacement and we will not pretend otherwise. Where it is providing mechanical protection and the thermal function sits elsewhere in the system, fiber replaces it well. Separating those two functions is usually the first useful step in the conversation.
Widely used for secondary and tertiary layers. Fiber replaces a folded and glued assembly with one formed part, which improves repeatability and shortens pack-out. The trade-off is change control: swapping a corrugated fitment is a minor change, while introducing a new formed component into a qualified pack usually triggers notification and re-validation. That timeline belongs in the project plan from the start.
From Requirement to Production
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01 Application Review
Which layer of the packaging system the component belongs to, the primary container or device dimensions and their variation, the assembly and inspection process, the distribution profile, and your supplier qualification and documentation expectations. The layer question is settled at this stage, before any geometry work.
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02 Design and Prototyping
Material route, wall structure, cavity geometry, retention and nesting behaviour are developed around the application. Prototypes are used to review fit against the real containers, the assembly sequence and compatibility with the outer pack.
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03 Validation Against Medical Criteria
Fit accuracy and retention with the actual containers, stacking and compression against your distribution profile, handling and drop assessment, and particulate assessment where cleanliness is a controlling requirement. Denesting trials where the line is automated. Test scope, methods and acceptance criteria are agreed with your quality function before tooling approval.
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04 Tooling and Series Production
Series tooling, tolerances, inspection points, batch documentation, change-control route and supply requirements are finalised. Production runs against the agreed specification, quality criteria and documented claims.
From Brief to First Sample in Four Weeks
For technically suitable projects, THECA can move from a complete packaging brief to the first molded fiber sample through a focused four-week route. In this sector the sample is the start of a qualification conversation rather than the end of the project, and the validation and change-control timeline sits outside the four weeks.
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Week 1 — Product and Packaging Design
We review product geometry, protection points, packing sequence and material route, then develop the molded fiber concept using approved samples, drawings or 3D data.
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Weeks 2–3 — Mold Manufacturing
Once the design direction is approved, the sampling mold is manufactured and prepared for trial production, with forming, release and dimensional requirements taken into account.
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Week 4 — Sample Production
The first molded fiber samples are produced for an initial review of fit, handling and packing sequence, ahead of application-specific validation and series-production decisions.
The four-week target begins after complete technical data, product samples or approved 3D files and written design-scope confirmation have been received. Customer approval delays, design revisions, application testing, series tooling and mass-production lead time fall outside this target.
Pharma & Medical Packaging FAQ
Can molded fiber be used as a sterile barrier?
No. The sterile barrier system is governed by a defined material and validation route, and THECA does not present molded fiber as a sterile barrier material. Fiber is applied to the secondary and tertiary layers around the barrier — positioning, organisation, protection and distribution. If your brief asks fiber to maintain sterility, we will tell you at the first review rather than after tooling has been discussed.
Is your ISO 13485 certificate enough for us to use fiber in a medical pack?
It is one input, not the answer. The certificate covers THECA's quality management system for the activities in its stated scope. It does not certify an individual product as a medical device, as sterile, as suitable for a sterile barrier or as approved for patient contact. Whether a given component is appropriate for your packaging system is determined by your own classification, intended use and validation work, supported by the specification and documentation we agree for the component.
How do you control particulate on fiber components?
Particulate behaviour depends on the material route, the forming process and any finishing step, and it is addressed per project rather than by a general figure. Where cleanliness is controlling, we agree the acceptable level, the assessment method and the production and handling conditions against your own standard before tooling. We do not publish a cleanliness class for molded fiber, because a number without a stated method and application is not evidence your quality function can use.
What happens to a fiber component during sterilisation?
That depends on the process and on where the component sits. Ethylene oxide, gamma irradiation and steam affect materials differently, and a component outside the sterile barrier may or may not be exposed at all. The exposure, the effect on the component's properties and any implication for its documentation are assessed for the specific process and the specific component. It is not assumed from the material.
Can you support our supplier qualification and audit process?
Yes, and it works best when the expectations are set at the specification stage. Batch identification, material route records, inspection points, change notification and retention periods are defined before series production so they are built into how the component is made rather than reconstructed afterwards. Tell us what your quality function requires and we will confirm what we can document and what would need to be established.
Can a fiber tray hold vials with the positional accuracy we need?
Often, but the achievable tolerance depends on the forming route and is agreed at the concept stage rather than promised in advance. Fiber does not hold the tolerances a thermoformed tray holds. What it can do is restrain each unit reliably with a controlled contact area, which is what prevents glass-to-glass contact and drift. We confirm fit and retention with your actual containers, including their manufacturing variation, before tooling is approved.
Tell Us Which Layer You Are Solving.
Send the primary container or device dimensions, the packaging layer you are specifying, your assembly and inspection process, the distribution profile and your supplier qualification expectations. Our engineering team will confirm where fiber belongs in your system, what documentation the component would carry, and the next technical step — including telling you plainly if the layer you are describing is not a fiber application.
- Dr. Engin Sarıkaya Commercial engin.sarikaya@wetheca.com
- Dr. Artunç Alptekin Technical artunc.alptekin@wetheca.com
- Dr. Eda Özay Sustainability eda.ozay@wetheca.com
Main line +90 258 244 00 43