Stopper
treatment

As aseptic filling lines become faster and batch values increase, the transfer of elastomeric closures becomes a critical step in contamination control.

When stoppers pass through the RTP into the filling isolator, the sterile process reaches a non-recoverable boundary. At that point, sterility must already be achieved and preserved. Any failure in preparation, sterilization or transfer can directly impact batch integrity.

At the same time, manufacturers face increasing pressure to reduce component costs, decrease dependence on specialized RTU formats and maintain greater operational flexibility.

These requirements place increasing importance on how stoppers are prepared, sterilized and transferred into the aseptic filling environment.

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STOPPER QUALITY SHOULD BE GOVERNED BY THE PROCESS REQUIREMENTS OF THE PHARMACEUTICAL MANUFACTURER, NOT BY SUPPLIER PACKAGING CHOICES.

Stopper quality must shift from a purchased attribute to a controlled manufacturing activity.

We enable manufacturers to define and achieve the required level of particle cleanliness, endotoxin reduction, siliconization, drying and sterility assurance through an integrated preparation and transfer process.

Bulk stopper preparation, sterilization and aseptic transfer are managed within a single process architecture, providing direct control over quality, contamination risk and operating cost.

QUALITY UNDER CONTROL

Particle reduction, component integrity and treatment uniformity must be achieved simultaneously. Continuous rotation promotes homogeneous exposure while limiting particle generation, preventing stopper coupling and preserving component integrity throughout the process.

ONE PLATFORM, MULTIPLE STERILIZATION STRATEGIES

The same platform supports stopper preparation and sterilization of machine parts, garments, Tyvek-packaged materials and cleanroom accessories. Dual-purpose utilization improves asset efficiency while reducing equipment footprint and operational complexity.

PRESSURE CONTROL

In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior.

±0.5°C UNIFORMITY

Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load.

DRY-LOADS

Critical components
emerge sterile, dry and ready for immediate use.

CANISTER PROVEN

We support advanced canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.

CDMOS AND LARGE PHARMACEUTICAL MANUFACTURERS

Relevant when flexibility, process ownership, supply chain independence and standardized preparation strategies must be maintained across multiple products and filling lines.

Why is transfer critical?

Transfer to the filling isolator represents one of the final sterile interfaces before product contact.

What is the benefit of the rotating drum?

Continuous rotation promotes homogeneous treatment while limiting particle generation, stopper coupling and mechanical stress.

Why process bulk stoppers instead of purchasing RTU stoppers?

Bulk processing allows manufacturers to define the required quality level through process control while reducing component costs.

Can the system be connected directly to filling isolators?

Yes. Dedicated transfer tanks and RTP integration support direct connection with aseptic filling environments.

Is the system only intended for stopper treatment?

No. The platform also supports sterilization of machine parts, garments and other cleanroom materials.

When is the economic benefit most significant?

In medium- and high-volume aseptic manufacturing where stopper consumption represents a significant operational cost.

Medical Devices

COMBINATION PRODUCTS

Drug-device combination products can bring together a thermosensitive drug, a complex delivery system and a protective package within a single sterilization challenge. For blistered prefilled syringes, the process must reach external surfaces, recessed areas and partially enclosed geometries without exposing the filled product to damaging temperatures. Sterilant penetration through the Tyvek® layer must therefore be demonstrated, together with microbial effectiveness inside the blister and around critical syringe components.

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Small Molecules

Cosmetics

HIGH-VISCOSITY PRODUCTS

Hyaluronic acid pre-filled syringes combine a thermally sensitive formulation with a pressure-sensitive container-closure system. Product performance depends on the molecular weight and rheological behaviour of the formulation, while moist heat progressively reduces viscosity as exposure continues. At the same time, heating increases the internal pressure of the filled syringe through liquid expansion and vapour pressure, potentially causing plunger movement, leakage or loss of container integrity.

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ATMP - genes, tissues or cells

Biotech

Small Molecules

Medical Devices

Primary Packaging

OSD

R&D and LAB centers

Cosmetics

STOPPER IN BULK

Internalizing bulk stopper preparation means directly assuming technical responsibility and controlling all critical quality variables before aseptic filling.

While ready-to-use (RTU) stoppers transfer preparation upstream to suppliers, handling bulk stoppers internally allows manufacturers to actively govern particulate, pyrogenic, microbiological, and physical condition, right up to the filling line, achieving consistent process performance and robust quality outcomes.

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Stopper
treatment