Standardized design of Plasma bags: A full-process analysis from materials to sterilization

1. Material selection

Plasma bags are usually made of medical grade materials, mainly polyethylene (PE), polypropylene (PP) or medical soft polyvinyl chloride (PVC, containing plasticizer DEHP). These materials must have good chemical stability, be non-toxic, odorless, and be able to effectively resist blood erosion. When selecting materials, their biocompatibility, chemical resistance, low permeability and low adsorption should be considered to ensure the stability and safety of plasma components.

II. Design and manufacturing

1. Structural design:
Bag: The plasma bag should have a certain thickness to ensure that it is not easy to break during use. It is usually designed to be transparent or translucent to facilitate observation of the appearance, color and state of the blood.
Pipelines and interfaces: Including input pipelines, separation cup interfaces, etc., use medical-grade materials to ensure the sealing and reliability of the connection.
Accessories: Such as protective caps, stop clamps, etc., use medical-grade polyethylene and other materials to ensure sterility and pyrogen-free.

2. Capacity specifications: The capacity of the plasma bag should meet actual needs. Common specifications include 600ml, 800ml, 900ml, 1000ml, etc. The capacity design needs to consider the needs during blood collection, storage and transfusion to ensure sufficient plasma supply.

3. Sealing and drop resistance: The plasma bag should have good sealing, and the seal should use medical-grade heat seal strips or zipper seals. The joints are flat and seamless to prevent blood leakage. Blood bags should have a certain degree of fall resistance and be able to withstand a certain degree of falling and collision to prevent leakage and damage during transportation and use.

III. Marking and packaging

1. Marking information: The plasma bag should clearly indicate the capacity, blood type, blood collection date, expiration date and other information. The mark should be printed in a waterproof and non-falling font, and the color should be in sharp contrast with the blood bag for easy identification.

2. Packaging requirements: The plasma bag should be leak-proof, shockproof, and waterproof. The packaging should have clear warning signs, such as "this side up" and "handle with care". The packaging should also indicate the production date, expiration date and other information for easy management and tracking.

IV. Sterilization

1. Sterilization method: Plasma bags need to be strictly sterilized during the production process. Common methods include gamma ray sterilization or high temperature and high pressure sterilization (such as 121°C saturated steam sterilization for 30 minutes). The specific method should be selected according to national and regional regulations and standards to ensure that the plasma bag has been thoroughly sterilized before use.

2. Sterilization Validation: The sterilization process needs to be validated to ensure that the sterilization effect meets the standards. The sterilized plasma bag should be subjected to sterility test and pyrogen test to ensure that the product is sterile and pyrogen-free.