SubscribeSkan AG discuss a validatable isolator process solution with a statistically based H2O2 Decontamination Process.
- Approved Validation
Isolator-Process Solutions - Statistically based
H2O2 Decontamination - Scientifically founded
Qualification Strategy - Professional
Customer Support
Your Aim
- A safe and easy to validate isolator solution, with H2O2 decontamination process, meeting your and the requirements of the authorities e.g. FDA, MCA, IKS.
- Not only assembled systems but a complete isolator solution, which forms a entity with the decontamination process.
- AH2O2 decontamination based on a scientifically founded process development.
- A statistically significant definition of the process performance and boundaries.
- Aclear and transparent cycle development methodology for decontamination, GMP-conformed documented.
- No waste of time with problems of D-value determination and suitability of biological indicators by using tested bio indicators with proven specifications.
- Save time by using scientifically based reference studies regarding critical questions of authorities.
- Not a surprise during qualification but a safe and fast testing of your requirements without any deficiencies of information.
- Professional and competent support and advice with pragmatic and validatable solutions.
All in all:
You don't want just an isolator and a H2O2 Systemin what you have to invest a significant amount of time.
You expect a professional and complete Isolator Process Solution, which fast and safe, meets your requirements.
You want to produce not to experiment
Our Solution
Validatable, integrated Isolator Process Solution
- dedicated customised as one unit for your process
- complete from DQ to PQ
Statistically based H2O2 Decontamination Process
- numerous FDA, MCA, IKS approvals
- scientifically founded process development
- statistically significant definition of process performance and boundaries
- based on accepted reference studies
- fast, safe, uncomplicated
Scientifically founded Qualification Strategy
H2O2 Cycle Development
- internationally successful utilisation
- highly accepted by the authorities
- published in international scientific papers
H2O2 Reference Studies
- influences of surface materials on the decontamination effect
- transferability of results to different systems
- D-value and suitability studies of biological indicators
- internationally published and accepted
Microbiological Qualification
- GMP-conformed realised and documented
Professional Customer Support
- competent and scientific support
- in house GMP-lab including reference isolator system
- fast, pragmatic, concrete
Your Profit
- an isolator process solution meeting exactly your requirements
- a fast validation without any deficiencies
- traceable and scientifically based processes
- time saving during qualification
- high acceptance by authorities e.g. FDA, MCA, IKS
- professional support and backup
- fast requalification without any problem
- massive time- and cost savings for your isolator project
Integrated Isolator-Process Solution
SIS 700 System
The integrated Solution for an aseptic Isolator System
The integrated SIS 700 Process is a highly efficient H2O2 decontamination method to guarantee aseptic environmental conditions.
This integration method was developed by the R&D department of Skan AG to ensure the optimal integration of the H2O2 decontamination process into an isolator system.
Because of this integrative view on isolator systems and processes Skan AG is able to supply complete customised solutions.
SKAN Filling Isolator with integrated SIS 700 H2O2 decontamination process.
H2O2 Decontamination Process
SIS 700 System
A consequent Process Development as Basis for a smooth Qualification
The H2O2 decontamination process SIS 700 is established in the international market
and successfully approved by the authorities e.g. FDA, MCA, IKS.
This process based on an unique process development which ensures a statistically significant correlation between physical process and microbiological result.
Studies of Skan`s R&D department conducted in a reproducible reference system, make basis data available for customised applications.
The transferability of the scientifically acknowledged basis data to customised systems, guarantees a safe and smooth qualification.
Qualification Strategy
From a customer specific H2O2 Cycle Development to a successful microbiological Qualification
The experts of Skan AG developed a transparent qualification strategy without any deficiencies suitable for all alternative sterilisation processes.
All around the world the users of isolator technology call on the support of Skan experts to transition than safely and smoothly into the production phase of their system.
H2O2 Cycle Development
The development of the H2O2 decontamination cycle is realised and attended by Skan AG with a team of experts.
Based on a proven methodology the process parameters are determined and adjusted according to the customer specific requirements.
The systematic approach and complete documentation enables a transparent process development, which can be presented as a closed chain of arguments to the authorities.
Microbiological Qualification
At the final process qualification the expert team of Skan AG stand by with all established microbiological and physical test methods.
GMP- conforming documentation completes the traceability of the entire qualification.
The switch to the production phase of the isolator system is guaranteed safe and without problems.
Customer Support
The Competence Center of Skan AG develop integrated and complete solutions for your application
The R&D department of Skan AG conducts research focusing on application in a lab under GMP standards and work on different problems and questions together with the customer.
By active scientific publication and an open information exchange with customers an intensive know-how transfer is guaranteed and the comprehension for the process become absorbed.
On special questions concerning decontamination or individual problems regarding application of isolator technology the expert team of Skan AG offers competent advice and a comprehensive support.
The Expert Team of Skan AG supports the whole Process Qualification
A team of specialists support the process qualification, flexible and responsible with the following services:
- Customised in house optimisation of decontamination cycles independent of the supplier.
- Carrying out of process qualification based on a transparent and complete qualification strategy
- D-value determination of biological indicators and customer specific microorganisms in a reference isolator
- Suitability tests of biological indicators and materials for routine use in the isolator system
