Atec Component Processing

Atec´s customer-centric component treatment systems offer tailor-made solutions for individual requirements.

Component Processing

Our systems guarantee the sterility of the components across all production stations - from component loading to component processing up to sterile transfer to the filling line - in one single process vessel.

The component quality at the filling line is essential for the efficacy of parenteral drugs. Sterile components ensure this effect through the controlled killing of microorganisms.

Advantages of Atec Component Processing

HIGHEST QUALITY FOR THE COMPONENTS

  • Effective washing (particle & endotoxin reduction)
  • No risk of clumping or sticking of components
  • Homogeneous siliconisation
  • Effective drying process for low moisture content

SAFE AND EASY COMPONENT HANDLING

  • Highest level of sterility
  • Mobile vessels enables processing and transport
  • Fully automated process & transfer to filling line

COST-EFFECTIVE COMPONENT PREPARATION

  • Minimal worker intervention
  • Large batch capacities possible
Needle Shields & Plungers Needle Shields & Plungers
Lined Seals & Plungers Lined Seals & Plungers
Caps & Lyo Stoppers Caps & Lyo Stoppers

Component Processing System

Atec develops and manufactures stopper processing systems for sterile filling lines. The stoppers are maintained in a process vessel throughout the complete process of stopper loading, processing and transfer.

1. Loading Station

For stopper loading, the process vessel is docked at a cleanroom-lift (Atec Lifting Device). The lift rotates the vessel to bring it into an ergonomic loading position. A funnel is placed on the vessel and stoppers are loaded from bags into the vessel. If loading stoppers through a clean room wall, a port system is used. The loading station is an integral part of the stopper processing system. Batch data can be entered at the loading station.

Loading vessel with Atec Lifting Device Loading vessel with Atec Lifting Device
Atec Process Station Atec Process Station
Atec Mini Processor Atec Mini Processor

2. Process Station

To achieve sterile filling requirements, stoppers must undergo the following process steps at the Process Station:

  1. Washing – Minimises endotoxins & particles
  2. Siliconisation – Applies homogeneous silicone layer
  3. Sterilisation – Reduces bioburden
  4. Drying – Ensures low moisture content
  5. Cooling – Eliminates clumping and sticking

Pressure and vacuum tests can be carried out before and after the process.

Stopper processing systems are characterized by:

  • Variable process volume up to 340 litres
  • High degree of drying by pulse drying
  • Effective endotoxin and particle reduction
  • Process reliability via batch tracking of process vessel
  • Treatment of a variety of components

3. Transfer Station

For the transfer of stoppers, the process vessel can be docked directly to the RABS or Isolator of the filling line. Atec manufactures both floor- and ceiling-mounted cleanroom lifts for positioning the process vessel.

At the RABS or Isolator a Rapid Transfer Port (RTP) is used to connect the process vessel. A transfer chute inside the RABS / Isolator is installed to guide the stopper or caps from the process vessel into the bunker from the filling line.

RTP Transfer

Alpha ports ensure a secure, sterile transfer and are typically hand-operated by a line worker. However, when the transfer point is difficult to access or poses safety risks to staff, manual operation is no longer an option. Atec therefore offers a fully-automated RTP solution which allows an automatic transfer connection of the process vessel to the filling line without intervention from a worker.

Bag Filling Equipment

The Atec stopper and cap bag filling systems are used for sterile transfer of pharmaceutical components into bags. Fully-automated cleanroom lift systems are used to position the vessels filled with sterile components over a VHP transfer isolator or RABS for sterile stopper or cap distribution into bags.

Alternatively, Atec’s vessels can be fitted with Biosteam ports for transferring stoppers or caps into beta-ported bags.The ported bags can then be connected to a RABS/Isolator just like an RTU or RTS supply.

Atec integrated an automated bag filling system into an interchangeable PSI L-Isolator flange to minimise contamination and ensure higher process security.