“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
Riboflavin is used as a tracer to visualize potential locations of contamination during normal manufacturing operations or in case of process malfunctions.
According to the new EU GMP guidelines, risk assessment studies must be performed to address potential cross-contamination inside a manufactured product. The riboflavin test is performed to determine how the active substance spreads (mechanical transfer) within an aseptic isolator during the filling process.
The Challenge
- Development and test of a suitable cleaning strategy
Our Solutions
- Definition of worst-case positions on the basis of riboflavin tests
- Simulation of several malfunction scenarios for the definition of suitable cleaning strategies
Your Advantages
- Test development on the basis of scientific knowhow
- Interdisciplinary team with extensive experience
- Overall approach for the identification and evaluation of risk factors associated with your specific process
- Different failure modes can be simulated or provoked to test your planned cleaning process
- 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
