SKANalytix
Spraying disinfection on surface in hospital.

“clean” is a service that 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.

Service portfolio

  • clean Check Material

    Application of clean Check Material

    Check the recovery of the reference contamination on different materials (as coupon samples), present in the isolator. The determined recovery value has to be used for the evaluation of the effectiveness of the cleaning process. The recovery varies depending on:

    • Spiked level of reference contamination on the surface
    • Topography of the material and material type

    The Challenge

    • Development and testing of a suitable cleaning strategy
    • Check of the residual contamination after the cleaning process

    Our Solutions

    • Target contamination with surrogate substance on different materials (defined by clean Mapping)
    • Measurement of the recovery, which is applied as a correction factor during the check of the effectiveness of the cleaning process (clean Check Isolator)

    The Advantages

    • Get access to scientific know-how with focus on sterile manufacturing process development
    • Our interdisciplinary team with extensive experience enables a holistic approach for the identification and evaluation of risk factors associated with your specific process
  • clean Check Isolator & Air

    Application of clean Check

    Check the effectiveness of the cleaning process and the operator safety during PCO. Cleanability studies are conducted at two different levels:

    • clean Check Isolator: test surfaces inside the isolator
    • clean Check Air: monitor airborne contamination inside an isolator during a PCO.

    The Challenge

    • Development and testing of a suitable cleaning strategy
    • Check of airborne contamination during normal operation and PCO

    Our Solutions

    • Measurement and assessment of airborne contamination with IOM sampler heads.
    • Target contamination with surrogate substance in critical areas (e.g. defined by clean Mapping)

    The Advantages

    • Get access to scientific know-how with a focus on sterile manufacturing process development
    • Our interdisciplinary team with extensive experience enables a holistic approach for the identification and evaluation of risk factors associated with your specific process
    • Performance evaluation of your own cleaning process by an independent third party
  • clean Mapping

    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
  • clean IP Print

    Application of clean IP Print

    Surface residual contamination assays are an essential element of any cleaning validation programme. Residue recovery factors show which contaminants can be recovered from the equipment surface and at what level. Recovery factors are determined through experiments in which every material of construction (MOC) used in the manufacturing equipment is spiked with known amounts of the substance of interest. The determined recovery values are used to evaluate the effectiveness of the cleaning process.

    The Challenge

    • Determine precise and accurate recovery factors for all the materials in your cleaning validation programme
    • Speed up residue recovery studies

    Our Solutions

    • Produce accurate chemical distributions at predetermined doses on different materials by using SKAN’s flexible, patented printing approach
    • Improve consistency and accuracy of your product recovery factors

    The Advantages

    • No more random and uncontrolled spiking studies where the pattern distribution is left to chance
    • Get access to scientific know-how with focus on sterile manufacturing process development
    • Our interdisciplinary team with extensive experience enables a holistic approach for the identification and evaluation of risk factors associated with your specific process
  • clean IP Indicator

    Application of clean IP Indicator

    Cleanability studies are performed by spiking contaminants on to coupons and then exposing them to various cleaning procedures and parameters. These studies might be conducted in a laboratory setting, by simulating the actual manufacturing cleaning conditions, or directly, by placing the indicator inside the manufacturing equipment. Coupons are then collected, and their surfaces are analysed for residues.

    The Challenge

    • Develop and verify the performances of your cleaning programs
    • Implement a data-driven and quantifiable cleaning evaluation processes

    Our Solutions

    • Manufacture your own process-specific indicator coupons by using SKAN’s flexible, patented printing approach
    • Take advantage of our portfolio of contaminants to test your cleaning strategies

    The Advantages

    • Identify the optimal cleaning cycles, chemical agents and variables necessary for your manufacturing equipment
    • Base your cleaning assessments on scientifically sound and measurable data
    • Develop, verify and routinely check the effectiveness of your cleaning programmes

Other services