Sterility testing

10 steps to your success

1st testing step: pre-wetting 1: Quality control According to the current Good Manufacturing Practice (cGMP), aseptic and aseptic-toxic pharmaceutical products require validated process procedures and sterility testing. These tests should be carried out in a defined clean room environment, which corresponds to the current production environment. Sterility testing confirms a successful sterile aseptic processing procedure and releases the batches.

2: State of the art Isolators have been standard for sterility testing and aseptic production for over 20 years. Isolators for sterility testing offer the highest level of safety for the test procedures and the products. The isolators can be placed in any environment, from unclassified rooms to EM GMP class D (ISO 8) rooms. With an air velocity of 0.45m/s, the working chamber meets the required product protection with EU GMP Class A (ISO 5) according to EN ISO 14644-1. 2nd testing step: filtration

3: Connect with our experience Choosing the right isolator for your specific requirements is no easy task. That is why the world-renowned sterility test isolators from SKAN are available in various configurations with a variety of options. Experts with many years of experience are ready to assist you in making the right decision. Together with you, they determine which confiA gurations meet your requirements. This includes analysing which transfer systems are needed, whether the size of the chamber fits the number of tests to be performed and whether an airlock or other transfer solution is required....

4th testing step: TSB culture media to detect aerobic bacteria 4: The best technology for you Manufacturing isolators has been our core competence for more than half a century. Thousands of satisfied customers worldwide trust in our highest quality standards and make us world market leader. SKAN’s sterility test isolators combine the best technology for modern decontamination and increase the safety as well as the productivity of your processes. The integrated skanfog® H2O2 decontamination technology has already established itself as a standard on the market with its short decontamination time...

5: Choose the right unit for your process SKAN offers several units and options for a variety of processes and applications. Choose the unit that fits your quality control, research or development process and your required safety level. Various predefined assemblies and options enhance your individual application and provide maximum flexibility. 5th testing step: FTM culture media to detect anaerobic bacteria 6: Your application defines the configuration The configuration of your individual sterility test isolator is based on an analysis of your processes and the number of tests you need to perform...

7: We accompany you through the project Each project is supervised by an experienced project manager and developed according to a defined quality project plan. This includes Factory Acceptance Test (FAT) at SKAN, our qualification service at the user site and the microbiological qualification package by our experts. Right from the start, you receive comprehensive and GMP-compliant documentation in provided SKAN’s proven quality. 8: Benefit from our material studies For the further development of our systems, we have conducted meaningful studies regarding material suitability and surface decontamination....

9: Take part in our experience In our SKAN Academy, we have been organizing general and specific training for our customers, agents and of course for our professional organising staff for many years. Benefit from this service and learn more about your systems and facilities. 9th testing step: incubating of canisters

10: Benefit from our worldwide customer service SKAN offers a worldwide lifecycle partnership with local support for the safe and lasting operation of your systems. Extensive spare parts inventories and the years of experience of our SKAN specialists can be quickly relied upon. Optional, customised service contracts open up a wide range of individual service options. 10th testing step: reading out by visual check and documenting the results

spectra The spectra isolator is the consistent answer to the requirements of the modern pharmaceutical industry in terms of the highest hygiene standards, high efficiency, automation and digitalisation. Preferred areas of application are sterility testing, quality control and industrial preparations. The integrated SKAN nanox® catalyst and the reduced overall height allow easy integration into almost any room. Sophisticated skanfog® decontamination technology ensures fast cycle times and helps accelerate your process and overall efficiency. Launched in 2019, spectra can be used for both aseptic...

Description of spectra isolator Built-in catalytic converter for exhaust air to room Control system Siemens or Allen Bradley PLC validated acc. to GAMP-5 HMI (Human Machine Interface) Zenon or Factory Talk SCADA (Supervisory Control and Data Acquisition) with batch report functionality and optional Ethernet Integrated leak test according to ISO 14644-7 Dimensions of the unit (overall) W x H x D Dimensions of the working chamber W x H x D [mm] Pre-defined integration of sterility testing pump (Merck Millipore or Sartorius) with liquid drain Working chamber with shelves at the back wall Integrated...

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