AFS – Point-of-fill sterile filtration

AFS
Point-of-fill sterile filtration

Automation of Single-Use Systems

Sterile filtration of vaccines and parenteral drugs before the filling step is an important requirement in terms of good manufacturing practices in the pharmaceutical sector. You want to make sure that it is carried out under the safest conditions: filter-integrity tests before and after production (PUPSIT – Pre-Use, Post-Sterilization Integrity Testing), sterility assurance and production data integrity are at the heart of the features of our automated AFS V2021 final filtration system.

AFS 2021 automates the transfer and final filtration of your products by adapting to your single-use systems that connect the finished product vessel and your filling equipment. The highly adaptable AFS interfaces with the most common filter-integrity testing equipment and the vast majority of sterile filters on the market.

Benefits

The automated AFS V2021 filtration system perfectly satisfies the needs of the pharmaceutical industries: feedback from production data (batch reports and audit trails) to the customer’s SCADA, compactness, flexibility in the configuration of the single-use assemblies used.

Your filtration system is CE-certified and satisfies all the requirements related to cGMP and GAMP5 good manufacturing practices.

Advantages

  • Compliant with GMP Annex 1
  • Designed for various filter sizes
  • Compatible with multiple brands
  • Flow regulation and monitoring
  • Requires minimal floor space

Options

Custom Sampling Configuration

Custom Sampling Configuration

Custom Scada Integration

Level of integration with the SCADA of the production line at the customer’s choice

Regulation of the filtration flow rate

Regulation of the filtration flow rate to the needs of your filling equipment

UPS

UPS

Barcode reader

Handheld barcode reader to scan SUS-assemblies

Technical Specifications

Elements Characteristics
Application
  • Final Filtration
  • In-line automated PUPSIT sequence
Frame
  • Stainless Steel 304/316L
  • Mobile (on wheels)
Filters
  • 1 or 2 filter(s) configuration
  • Multi-brand
  • All standard sizes up to 30″
  • Customizable slope of filter(s)
Flow

Adjustable to the needs of the filling equipment

Dimensions

Customizable, minimal footprint : 850 x 10(0 x 1975 mm

Electricity
  • Power supply : 230V or 120V
  • IP54
Interface

Touchpanel 15″ or 17″

Standard Integrity Testing Equipment
  • Startocheck
  • Palltronic
Integration
  • Machine integration & connection to Scada / MES
  • Custom mechanical configuration
  • Process recipes customization
Data Monitoring
  • Flow, pressure, weight
  • Automatic batch record
  • Audit trail
Certification
  • Europe : CE
  • North-America : UL

Technical Datasheet

Collaboration

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