Plasma Safety/Product Quality
Safety
Adults from all walks of life provide the plasma that is the basis for lifesaving plasma protein therapies. The quest for safety begins by finding healthy, committed donors.
First, all potential donors are required to undergo a pre-donation physical and tests for syphilis, hepatitis, human immunodeficiency virus (HIV, the virus that causes AIDS) and other diseases. Potential donors must also complete in-depth questionnaires about their medical history and lifestyle. Those who satisfy all our criteria provide plasma donations on a periodic basis and undergo a medical screening prior to each donation.
Each plasma unit is held in storage for a specified period of time before it is released for processing.
This "inventory hold" allows manufacturers to avoid specific units should a donor subsequently test positive for a viral marker during the holding period.
Testing is the next step in ensuring that the plasma we use meets the highest safety standards. Located in Knoxville, Tenn., ZLB Plasma operates one of the world’s largest and most sophisticated plasma testing facilities. Our teams of experts in Knoxville and in Göttingen, Germany use highly sensitive laboratory tests to check each plasma sample for viruses before the plasma is approved for manufacturing.
The next stage of safety measures are combinations of heat, filtration or solvent-detergent treatment in the course of the purification process. These processes are designed to kill or remove enveloped and non-enveloped viruses or other pathogens, e.g. prions, without damaging the valuable plasma proteins.
Our scientists continually work to improve our viral elimination techniques to destroy potential emerging pathogens as well.
CSL Behring also works to ensure the health and safety of our employees, contractors, visitors and the community. We actively encourage safe work behaviors and hold every employee personally responsible for environmental safety.
Quality
CSL Behring’s safety processes were among the first to be certified by the Plasma Protein Therapeutics Association’s internationally recognized safety program, QSEAL. Regular inspections ensure that our company complies with global industry standards.
The International Quality Plasma Program also recognizes CSL Plasma for its plasma collection safety and quality standards. This program establishes voluntary standards that meet or exceed regulations around the world. To become certified, each of our plasma collection centers must meet these standards and pass all random inspections.