By Alpa Patel, Department Scientist, Hospital Reprocessing, BS, RM(NRCM)
For many years Nelson Laboratories has been providing tissue process validation for manufacturers, tissue banks and organ procurement organizations (OPOs). Nelson Labs provides a full gamut of tissue testing services to the tissue industry.
Nelson Labs is a leader in disinfectant and antibiotic testing for process validations and can help customers develop and customize protocols to meet specific needs or for troubleshooting problems. Nelson Labs’ testing procedures demonstrate the process effectiveness against bacterial and fungal contaminants.
- Help companies determine optimizations for their process by evaluating steps in the process, ultimately reducing costs.
- Provide good validation practices that help the industry increase the confidence in the tissue and helps raise product quality and assurance.
- Assure companies are meeting best practices by providing validation paperwork which can be used in an FDA audit. Generally it is better to have a third party conduct the validation rather than an internal laboratory.
- Help organizations develop and change a process if it fails a validation. A third-party laboratory such as Nelson Labs can provide guidance in improving the process.
Validation demonstrates a company’s process is decontaminating the tissue to levels they accept. Nelson Labs conducts simulation testing using a panel of microorganisms to represent those that can be present on tissue. This helps the tissue bank determine how well the contaminants are being eliminated to insure their process is providing tissue which is not infectious and is safe for a patient.
Organizations can contact Nelson Labs for additional information on tissue process validation.