Skip to content
Close
SEARCH

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.

Request more information

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.

Stopper-treatment-graphic
Elemento grafico rotondo

LOWER TOTAL COST OF OWNERSHIP

Bulk stopper processing reduces dependence on RTU formats and associated packaging costs, especially for high-volume production delivering a short return on investment.

Elemento grafico rotondo

STERILITY BEYOND STERILIZATION

Sterile transfer tanks, controlled overpressure and RTP integration preserve the sterile state achieved during processing and support transfer to the filling environment.

Elemento grafico rotondo

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.

Elemento grafico rotondo

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.

DEDICATED PROCESS CONTROL FUNCTIONS

Stopper preparation requires control of cleaning, sterilization, drying and sterile transfer.

We integrate:

  • Immersion washing and rinsing
  • Siliconization
  • Saturated steam sterilization
  • Controlled drying and cooling
  • Sterile transfer tanks
  • RTP integration
Proven by numbers

PROVEN BY NUMBERS

>130
systems installed worldwide 

40
milions standard 20mm Serum Stopper medium capacity 

15
months ROI – return of investment

x2
double purpose the machine can handle machine part as well

WHEN SHOULD YOU CHOOSE OUR TECHNOLOGY

HIGH-VOLUME MANUFACTURING

Particularly relevant when annual stopper consumption reaches levels where component cost, process efficiency and asset utilization significantly impact operating expenditure.

ASEPTIC FILL & FINISH

Designed for applications where stopper preparation, sterilization and transfer must support aseptic manufacturing and contamination control requirements.

POWDER AND LYOPHILIZED PRODUCTS

Suitable for processes where elastomeric closures must be prepared and transferred under controlled sterile conditions prior to product filling or lyophilization.

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.

FREQUENTLY ASKED QUESTIONS

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.

Request more information

Image Box - Camera

Scritta legata al
mondo della case
studies e molto
altro

Description Box - Camera
CASE STUDIES

Lorem ipsum dolor sit amet consectetur. Varius nulla nulla risus ullamcorper urna ut nulla tristique.

Discover more

Customer so closer is not a promise of proximity.
It is a way of working.

A global network designed to keep Fedegari close to the customer, close to the process and close to the decisions that make sterile manufacturing safer, more reliable and more valuable over time.