Automated Leak Testing for Sterile Pharmaceuticals

Some packaging materials require 100% integrity testing according to Annex 1 of the EU GMP guidelines. In order to meet those requirements and to not reduce production outputs, high speed inspection systems are put into place. High speed machines reach up to 600 test samples per minute. The size of the machine is dependent upon the size of the test sample and the required leak sensitivity.

R DPPA

Annex 1 of the EU GMP guidance requires a 100% CCIT of fusion sealed sterile pharmaceutical containers. This includes blow-fill-seal ampoules and bottles. Besides that, USP <1207> provides guidance for sterile drug product packaging for small and large volume parenterals including BFS and FFS containers. Our integrity testing solutions for BFS containers allow to fully meet those requirements.

High sensitivity of the LFC method®

Leak sizes of down to 5 microns can be detected.

Reliable product handling

The product handling system is adjusted to different container shapes and sizes and ensures high throughputs and minimum downtimes.

Easy format changeover

The toolless format change over ensures short downtimes during product changes.

Our automated CCI testers for blow-fill-seal containers use the latest generation of vacuum decay testing procedures allowing a highly sensitive and robust measurement for multiple product types.

Advantages of the LFC method® for BFS

Vacuum decay and in specific the LFC method® provide several advantages for 100% high speed integrity testing of fusion sealed containers such as BFS and FFS containers

Testing of entire BFS product

One advantage is that the entire sample is tested at once while for instance, the HVLD methods allow only a partial measurement and therefore do not provide fully accountable test results.

Wide range BFS sizes and shapes

The test method can be applied for non-conductive contents as well as for different shapes and sizes of the packaging on the same system. Therefore, the versatile use of the equipment helps CMOs to run multiple presentations on one line therefore reducing investment costs for multiple systems.

Features

  • Up to 60.000/min
  • Integrated LFC method ®
  • Sensitivity of down to 5 microns
  • Testing of entire BFS container at once
  • Applicable for various shapes and sizes of BFS containers
  • Applicable for oily and non-conductive liquids in BFS containers
  • Applicable for BFS with low filling volume
  • Non-destructive test method
  • Deterministic test method preferred acc. USP1207
  • Test method according ASTM – F 2339
  • Design according GMP guidelines
  • Data Handling in compliance with 21 CFR part 11
  • Reliable product handling
  • Easy and tool-less format changeover

R DPX

The R DPX is an inspection platform for 100% leak testing of multiple types of primary packaging containers in production environments. Being able to process both liquid, powder and lyophilized products, the R DPX provides the versatile use in multi-product production lines.

Test method variety

The test procedures can be configured to various product and package configurations.

Reliable product handling

The robust handling systems of the R DPX guarantees gentle product transfers minimizing the risk of production stops or the cause of defects.

Toolless format changeover

The change in between different formats can be done quickly as no tools are required to do so.

The R DPX is an automated CCI tester for pharmaceutical primary packaging containers. It uses the latest generation of vacuum and pressure decay testing procedures allowing a highly sensitive and robust measurement in high-speed production facilities.

LFC method ®

The LFC method® provides a highly sensitive 100%leak test at high production speeds for liquid filled and lyophilized primary packaging containers.

Various packaging and product types

The R DPX can process glass and plastic vials, ampoules and cartridges. Besides liquids it can test solid, powder and lyophilized products.

GMP design

The R DPX is designed for the use in GMP environments following international guidelines.

Features

  • Up to 600/min
  • Format range from 1ml up to 250ml
  • Testing of entire container at once
  • Applicable for vials and ampoules
  • Applicable for glass and plastic containers
  • Applicable for liquid, lyophilized and solid products
  • Applicable for non-conductive products or low filling levels
  • LFC method ® with high sensitivity
  • Non-destructive, deterministic test method preferred acc. USP1207
  • Test method according ASTM – F 2339
  • Design according GMP guidelines
  • Data Handling in compliance with 21 CFR part 11
  • Reliable product handling
  • Toolless format changeover

R FSB

Annex 1 of the EU GMP guidance requires a 100% CCIT of fusion sealed sterile pharmaceutical containers. This includes fusion sealed bags for injections. Our automated bag testing platform can test up to 150 bags per minute.

Robot handling system

Fully automatic handling system for large bags by means of multi axis robots.

Gentle force sensors

Gentle sequeezing of bags for leak detection in critical areas of bag by force sensors.

Fully integrated

Testing process and bag handling system is fully integrated.

Features

  • High throughput (150/min)
  • Multiple bag sizes (250ml, 500ml, 1000ml)
  • Full integration in MES 
  • Applicable for non-conductive products
  • Applicable for products after thermal sterilization
  •  Non-destructive test method
  •  Deterministic test method preferred acc. USP1207
  •  Reliable product handling
  •  Easy format changeover