YY 0326.3-2005Plasmapheresis centrifuge apparatus for single use - Part 3: Plasma bags (English PDF)

3.1 Container for plasma

It refers to bag container that is designed to be able to connect with the outlet of centrifuge bowl as specified in YY 0326.1 and used to collect plasma.

3.2 Shelf-life

It refers to the period between sterilization time and expiration date; containers for plasma cannot be used to collect plasma if it is beyond the expiration data.

4.1 Type and specification

A container for plasma consists of the bag body and intake tubing. The specification of containers for plasma is divided into 600 mL, 800 mL, 900 mL and 1000 mL and so on, according to its nominal capacity.

4.2 Marking example

Containers for plasma are marked by using descriptive words "containers for plasma", the number of this Part of YY 0326, and the nominal capacity of the containers for plasma. For example, the container for plasma complying with the requirements of this Part YY 0326 with capacity of 800mL is marked as. Container for plasma YY 0326.3 800 mL

5.1 General rules

The containers for plasma shall be designed and manufactured to provide safe and convenient for the collection, storage, processing, transfer and separation of plasma. The containers for plasma shall minimize the hazards caused by microbial contamination to collect plasma, and shall be suitable for the centrifuge bowl as specified in YY 0326.1.

5.2 Intake tubing

5.2.1 There shall be an intake tubing in containers for plasma to collect plasma. The intake tubing shall be equipped with a connector matching with centrifuge bowl in accordance with YY 0326.1 and protective jacket.

5.2.2 There shall be no rupture and be insolated with the outside when the intake tubing is in normal use.

If the container for plasma is sterilized by ethylene oxide, the ethylene oxide residue shall not be larger than 10µg/g.

Note: GB/T 14233.1 and GB/T 16886.7 specify the testing method and release control of ethylene oxide residue. Adopting the dialysis materials that are easy for in-out of ethylene oxide on single package (such as adopting dialysis paper on one side, while the other side is plastic film composite packing bag. Or attach dialyzing paper on perforated packing paper) can effectively reduce the ethylene oxide residue.

6.4 Biological requirements

6.4.1 General rules

Containers for plasma shall not cause adverse effects to plasma, and shall not release toxic, cytotoxic, antibacterial, sterilization, pyrogen or hemolysis substances.

Note: GB/T 16886 gives the general toxicity test methods (see Bibliography).

In addition to tests given in clauses C.2 - C.5, the test given in C.6 can be used as guidance.

6.4.2 Microbial impermeability

When test is done according to C.2, containers for plasma shall not be impervious to microorganisms.

6.4.3 Compatibility

When the test is done according to clause C.3, clause C.4 and clause C.5, the container for plasma shall not produce any heat source, toxic or hemolytic reactions substance to plasma.

9.1 General rules

The label of containers for plasma shall comply with requirements of relevant national laws and regulations and requirements specified in 9.2 to 9.5. The graphic symbols given in YY 0466 can be used.

9.2 Labels on containers for plasma

If possible, the label shall include the information specified in following a) to i). However, if the space of label is too small, d), e), f) and g) are allowed to be given in instructions for use and not given on the label.

a) Description of the intended use;

b) Volume (mL) or mass (g) of collectable plasma;

c) Explanation for sterile and non-pyrogenic limit conditions;

d) Explanation of prohibition of use for any visible signs of deterioration;

e) Explanation for ventilation is not required;

f) Explanation for the single-use of containers for plasma;

g) Description of the use of containers for plasma;

h) The name and address of the manufacturer and/or vendor; i) Batch number. […]