SKANalytix
Scientist in laboratory looking at a sample through a microscope, NRW, Germany

With millions and billions of humans taking more medicines than at any time in history, an unanticipated drug safety problem can rapidly escalate to become a major public health threat.

Tackling this potential threat demands a multifaceted safety effort based on interdisciplinary scientific teamwork throughout the value chain.

SKAN accepts this responsibility and offers analytical services to jointly identify potential hazards and to protect customers’ products.

Service portfolio

  • Hydrogen Peroxide Trace Analysis

    Trace Analysis

    The analysis for H2O2 traces is carried out with a sensitive enzyme-linked colorimetric method which uses a fluorescence signal.

    The concentration of H2O2 in a given range (ng/ml) is linearly dependent on the signal of fluorescence, which is measured with a suitable spectrometer.

    Why a H2O2 -Trace Analysis?

    In isolators, different H2O2 concentrations occur. For safety as well as quality reasons, it is important for the user to know how much H2O2 is in the gas phase as well as in the packaging materials used and especially in the end product.

    Our method can therefore measure H2O2 traces.

    The Challenge

    • Ensure that H2O2 residues, entering final drug product containers (e.g. vials, syringes etc.), are within acceptable ranges (this affects the decision on the target concentration after the aeration phase)
    • Absorption of H2O2 residues on empty glass surfaces (vials, syringes), open (unstoppered) filled vials or syringes, or filling line tubings

    Our Solutions

    • Measurement of H2O2 ingress into packaging materials
    • Investigation of H2O2 uptake by certain materials (e.g. stoppers)

    The Advantages

    • Test development based on scientific know-how
    • Interdisciplinary team of experts with extensive experience
    • Different target concentrations of H2O2 can be simulated (exposure to a constant concentration of H2O2 as low as 30ppb)
  • H2O2 Sorption & Diffusion

    Measurement Performance

    Two different measurement modes are possible:

    • Sorption measurement according to VDI guideline 2083 part 20
    • Diffusion measurement, and estimation of the transmission rate for H2O2 (ppm/h) through flexible plastic materials

    The expected H2O2 ingress during the decontamination cycle can therefore be estimated to evaluate the suitability of various packaging materials.

    The Advantages

    • Test development based on scientific know-how
    • Interdisciplinary team of experts with extensive experience

    The Challenge

    Evaluation of different plastic materials for process suitability:

    • Measure the H2O2 transition rate through flexible packaging materials (this affects the decision on the target concentration after the aeration phase)
    • Measure the absorption of H2O2 on various materials inside the isolator, such as filling line tubing or flexible packaging materials, to minimize outgassing of H2O2 after the end of the decontamination cycle

    Our Solutions

    • Measurement of the H2O2 transition rate into packaging materials
    • Investigation of H2O2 uptake and outgassing kinetics of materials (e.g. stoppers)
  • DECO-Bioburden

    Application

    An aseptic environment is essential to the manufacture of sterile drug products. To ensure aseptic processing conditions, isolators are routinely decontaminated with hydrogen peroxide. Successful decontamination cycles are evaluated with biological indicators containing spores of Geobacillus stearothermophilus with an increased resistance to hydrogen peroxide.

    However, when bacteria are isolated in production sites, there is often a lack of information on their susceptibility. Additionally, any type of surrounding matrix may alter the efficiency of decontamination.

    The Challenge

    • Limited available data on resistance of isolates against vaporized hydrogen peroxide
    • Unknown effect of residual matrix surrounding microorganisms

    Our Solutions

    • Analysis of decontamination behavior of isolates in comparison to commercially available BI
    • Customization to your in-house isolates or standard reference strains up to BSL-2 to match your specific process
    • Assessment of effect of organic microenvironment encasing bacteria
    • Evaluation of decontamination in worst-case situations

    Your Advantages

    • State-of-the-art facilities including BSL-2 laboratories as well as SIS and SKANFOG decontamination technologies
    • Interdisciplinary team with extensive analytical and biological experience
  • H2O2 Impact on Sterility Testing

    Application

    Sterility tests are required by regulatory agencies to confirm the absence of microorganisms in product.

    Tests are routinely performed under aseptic conditions in isolators to prevent false positive results. Precautions should also be taken to avoid false negative results. Residual H2O2 after decontamination might pose a risk to sterility testing by altering properties of growth media or killing present microorganisms, leading to false negative results.

    The Challenge

    • Confidence in sterility testing data obtained after decontamination cycles
    • Residual hydrogen peroxide might negatively impact media components or falsify outcome of sterility tests

    Our Solutions

    • Analysis of trace amounts of residual H2O2 after decontamination cycles
    • Evaluation of killing effect on microbes
    • Simulation of sterility testing in worst-case situations

    The Advantages

    • Test development in compliance with USP <71>
    • Interdisciplinary team with extensive analytical and biological experience
    • Customisation to your in-house isolates or standard reference strains up to BSL-2 to match your specific process
  • Ozone Challenge Test

    Application of Ozone Tests

    In a SKAN electron beam tunnel, different concentrations of O3 are generated at different rates depending on the process conditions and parameters. Usually the ozone is eliminated very efficiently by the exhaust and ventilation system. Nevertheless, it may be important for product quality reasons to investigate how much O3 is generated in the air and potentially transferred to the desired product.

    SKAN has a standardised analytical procedure to determine the amount of ozone diffused in water. Any sample material can be exposed to a desired ozone concentration.

    The Challenge

    • Product sensitivity to traces of ozone
    • Ozone effect on product must be determined for risk analysis

    Our Solutions

    • Standardised fabrication of different ozone concentrations
    • Simulation of exposure to defined concentrations of ozone

    The Advantages

    • Test development based on scientific Know-How
    • Interdisciplinary team with extensive experience

Other services

SKANalytix

Analytical services provided by SKAN analytics experts

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SKANalytix

Analytical services provided by SKAN analytics experts

In addition to the successful operation of isolators and plants, SKAN also supports its customers with SKANalytix in the area of data analysis, data evaluation and documentation. To meet the different requirements SKAN offers the analytical service packages active, clean and persist.
The services include the analysis of the cleanability of isolators, the evaluation and development of individual cleaning processes, the determination of suitable packaging materials and the H2O2 influence on sterility tests.

It goes without saying that we follow the standards of “Good Manufacturing Practice” (GMP) as well as common standards and guidelines both in the execution and documentation of services.

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clean

Supporting you in developing an effective cleaning strategy

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Clean icon

clean

Supporting you in developing an effective cleaning strategy

Clean addresses the question “How clean does the production line need to be to prevent any risks that could potentially arise from contamination?”.
“It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.”
and further on “The ability to detect the harm (detectability) also factors in the estimation of risk.”
SKAN offers the clean service portfolio to strongly support our customers in developing effective cleaning strategies and ultimately to prevent harm to the patient.

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persist icon

persist

Select the best material for your process

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persist icon

persist

Select the best material for your process

In the life science industry, the importance of choosing materials that can stand up to repeated exposure to harsh chemicals is becoming more and more important.
Do you need to check whether your products and product packaging are resistant to different chemical agents?
Do you want to know how your products, product packaging, or the materials chosen to manufacture them will perform when subjected to different factors during production that could affect their final properties?
We check whether your materials are resistant to the chemicals, liquids and gases that will affect them later in the production process and entire product life cycle.

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