clean IP – Indicator & Print

Setting satisfactory cleaning efficacy requirements is a key aspect of any successful cleaning validation campaign. Developing and screening different cleaning approaches require a systematic, scientific approach, taking into account economical boundaries.

Chemical printing technology

• Produce chemical distributions at predetermined doses on different material surfaces (metal, glass and polymers)
• Standardize contamination distribution patterns to reduce/eliminate variation in your tests
• Improve consistency and accuracy of your product recovery factors
• No more operator dependent artefacts
• Create your own cleanability material library thanks to a systematic dosing approach
• Generation of (custom) cleaning performance indicators (CPIs) to guide your bench and field studies
• No visual pass or fail inspection but based on quantitative assessment of the residuals
• Set and perform visually clean (VC) inspection & studies according to GMP practices

• 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