History
BioLife originated in this state.
What is New York.
The number of in-house QC testing samples needed for a BloodStor 100 lot which had 570 acceptable units from manufacturing.
What is 0?
A set of 6 methodologies and tools used to improve business processes by reducing defects and errors, minimizing variation, and increasing quality and efficiency.
What is Six Sigma?
BioLife claims compliance to this standard for medical devices.
What is ISO 13485?
BioLife has been named one of Washington’s 100 Best Companies to Work for this many times.
What is 4?
The minimum lux value required for an inspection station.
What is 3750?
A principle with the goal of minimizing rework.
What is Right the First Time?
A nonprofit organization that develops and publishes standards for drug substances, products, excipients, and dietary supplements in the United States.
What is USP (United States Pharmacopeia)?
A graph used to show if there is a relationship between two variables.
What is a scatter plot?
The term for an uncontrolled cryopreservation media used by many academic researchers.
What is homebrew?
We use this type of pipette when pipetting into a 96-well plate.
What is a multi-channel pipette?
A production process based on an ideology of maximizing productivity while simultaneously minimizing waste.
What is lean manufacturing?
The FDA guideline which details the criteria for data integrity requirements.
What is 21 CFR Part 11?
BioLife moved to Bothell, WA in this year.
What is 2007?
The minimum score needed to pass the inspection qualification quiz.
What is 80%?
The Japanese word for improvement.
What is Kaizen?
The European equivalent of the FDA.
What is EMA (European Medicines Agency)?
A process map that display the sequence of steps in a system.
What is a flowchart?
BioLife's cryopreservation media is used in this number out of the 6 approved CAR-T therapies.
What is 5?
The minimum quality of water required for QC testing.
What is DI water?
A methodology for organizing, cleaning, developing, and sustaining a productive work environment.
What is 5S?
A system for ensuring that products are consistently manufactured and controlled according to quality standards.
What are Good Manufacturing Practices (GMP)?
A graph used to determine if a process is under a state of control.
What is a control chart?