Cryopraxis Collection Kit
Cryopraxis mastered a “collection kit” which permits and/or contains:
- complete traceability of all events from collection through transportation and reception;
- everything needed for safe and efficient collection (nothing is needed or required from the hospital);
- all documents (legal, commercial and medical) are there;
- records and complete data about the sample, mother and baby, physician, hospital, freight, temperature, etc
Basic definitions
Collection: Drawn of blood cells from the umbilical cord vein after birth, similar to collection of whole blood. Cryopraxis developed and validated a process (combined collection) which takes place in two steps: while the placenta is in uterus and after the placenta has been delivered (ex uterus). The blood is allowed to fill in the cord blood bag by gravity.
Transportation: Shipping methods must be well-designed in order to preserve the integrity and function of cord blood product as well as to protect the safety of people involved in the shipping process. This method has been validated to allowing the best quality of cord blood cell collected from hospital onto processing facility. |
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Processing: A series of technical, validated proceedings that goes from red cell depletion, leukocyte concentration, addition of specific cell protecting/stabilizing solutions, quality analysis, to allow the sample to be ready to freezing and long term storage under ultra-low temperature.
Quality Control Analysis: Sample processing are inspected in developing systems to ensure products (e.g. collection kits) or services (collect, process, etc) are designed and produced to meet or exceed cGMP requirements. These systems are often developed in conjunction with other divisions (marketing, management), using a cross-functional approach.
Freezing: SSub-zero temperature; Freezing is a common method of biological material preservation for it slows both decay and the growth of micro-organisms and, by turning water to ice, makes it unavailable for bacterial growth and chemical reactions. In a cryogenic storage tank filled with liquid Nitrogen, samples are submitted to temperature of -320.80 Fahrenheit (-196 Celsius) degrees.
Extreme Low Temperature Long Time Storage: Used to cooling/freezing and storing cells, tissues, or organs at very low temperature to keep them from decay or lost. Frozen cells or tissue samples, if adequately performed, will keep them intact, functional and biologically viable. Adequate cryogenic processing will carry samples from body or room temperature to -112.00 Fahrenheit (-80 Celsius) degrees, then to -320.80 Fahrenheit (-196 Celsius). At these low temperatures, biological activity, including the biochemical reactions that would lead to cell death, stops.
Thawing: To change from a frozen solid to a liquid by satisfactory warming. This is a very delicate and important process as it means bringing the biological sample back to room/body temperature. Technically validated proceedings must take place in order to prevent recrystallization and consequent cell damage or death.
Quality Assurance: Management method of guaranteeing high-quality product and service standards are established, trained and implemented. Quality assurance, at Cryopraxis, is a comprehensive management system that reaches total quality management having the ultimate objective of achieving zero defects. |