Automated CCI Tester
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 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 2338
- Design according GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Reliable product handling
- Toolless format changeover
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/h
- 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 2338
- Design according GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Reliable product handling
- Easy and tool-less format changeover
R DPPB
Terminal sterilization in an autoclave or with dry heat are options for achieving sterility after the filling of BFS plastic bottles. The conditions during the sterilization process can affect the shape of the bottle negatively – deformation and distortion will occur, resulting in a significant difference from the "designed" shape.
The R DPPB leak tester has been designed to compensate for such uncertainty and ensure high availability. Through its tried and tested LFC method® for detecting smallest leaks paired with a wide variety of manageable bottle sizes it is the ideal solution for 100% inline testing of BFS bottles.
High sensitivity of the LFC method®
Detection of smallest leak sizes in the entire BFS-bottle
Flexible
100% inline testing of multiple bottle formats with throughput from 1’000 up to 5’000 bottles/h
Reliable operation
Special designed transport system incl. control system
Intuitive operation
MAVIS operation system and OPC server for network integration
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. One advantage is that the entire sample is tested (full body test) 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
A system with this test method can be used for different products (conductive/non-conductive, flammable, sensitive...) as well as for different packaging shapes and sizes. CMOs can therefore test different products on one and the same line, so that investments in several systems can be avoided. BFS bottles with a filling volume of up to 1000 ml can be tested.
Reliable transportation
The leak testing of Large Volume Parenteral (LVP) bottles presents challenges such as container instability due to the soft and warm material right after the BFS process in combination with bottle weight. We offer various solutions for perfect inspection and careful transport.
Features
- Leak testing of LVP BFS bottles (stable and non-stable)
- Testing with LFC method® for highest sensitivity
- Full container body integrity check
- Testing of conductive and non-conductive liquids
- MAVIS operating system for simple operation
- Testing without impact on product
- Testing of flammable liquid
- No modified headspace required
- Quantitative determination of leakage
- Deterministic test method preferred acc. USP<1207>
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
SPECTRA HSX
The verification of quality relevant attributes of the headspace conditions e.g. in lyophilized and liquid filled vials, requires non-destructive and robust inspection technologies. The SPECTRA HSX platform impresses with its highly sensitive laser system and the flexibility to be configured for individual requirements for automated Headspace Analysis. Headspace Analysis may be used for nitrogen purging efficiency, vacuum verification or container closure integrity testing (CCIT) for small volume parenterals (SVP).
The SPECTRA HSX is an inspection platform developed for non-destructive Headspace Analysis for pharmaceutical packages with modified headspace conditions. Headspace Analysis may be used for nitrogen purging efficiency, vacuum verification or container closure integrity testing (CCIT).
Due to the continuous developments of the laser system it can be used for the highest requirements and provides the option to add further inspection technologies. Depending on the given conditions and requirements, up to ten test heads can be integrated. By increasing the number of test heads both the throughput and the sensitivity can be improved.
Inspection of multiple gases
With our newest laser generation we reach industry leading sensitivity. Optionally, two different laser heads can be integrated to check for both the partial pressure of oxygen or carbon dioxide and the total pressure inside the test sample.
Integration of additional inspection methods for vials
The integration of NIR spectroscopy modules for moisture detection in lyophilizates or barcode readers for container identification is optional. The combination with other inspection platforms such as the automated visual inspection platform is also possible.
Latest generation of HSA lasers
With our latest Head Space Analysis generation, we are setting new milestones in terms of sensitivity and inspection speed.
Integrated online calibration system
To verify the correct calibration of the HSA system during multiple-hour production runs, an online calibration tool was integrated to ensure maximum process reliability.
Integration of multiple test heads
The SPECTRA HSX 500 platform can accommodate up to 10 test heads providing the highest sensititity.
Different solutions for different customer requirements
We offer 3 different automated Headspace Analyzer platforms for different production speeds.
SPECTRA HSX 100
is a mobile and very compact inspection platform for pharmaceutical packages such as vials or ampoules. Glass or plastic containers from 2 ml up to 100 ml can be inspected at a speed of up to 100 test samples per minute.
SPECTRA HSX 300
is a compact inspection platform. The system is capable of testing 2ml vials to LVP bottles or other packaging types at a speed of up to 300 test samples per minute. Depending on the given conditions and requirements, up to two test heads can be integrated.
SPECTRA HSX 500
the SPECTRA HSX 500 qualifies for the highest requirements and provides the option to add further inspection technologies. Depending on the given conditions, up to ten test heads can be integrated. By increasing the number of test heads both the sensitivity and throughput (up to 500 samples per minute) are improved.
Features SPECTRA HSX
- Up to 500/min
- 2ml up to 100 ml containers
- Non-destructive head space analysis of vials, syringes, ampoules
- Deterministic test method preferred acc. USP1207
- Applicable for glass and plastic containers
- Applicable for liquid, lyophilized and solid products
- Designed according to GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Reliable product handling
- Toolless format changeover
- Optional integration of visual inspection systems
- Optional integration of 2D DataMatrix Code reader
- Optional integration of NIR Module for residual moisture and lyo defects
