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3pc-042u2005a science- and risk-based strategy to qualify sterilised prefilled syringes as primary packaging material in a hospital pharmacy

by:Caodahai     2020-03-23
In order to improve the safety of medication in hospitals, the Joint Commission recommended the implementation of ready-made international standardsto-administer (RTA)drugs.
Many hospital pharmacies promote this in aseptic filling of polypropylene monomeruse syringes.
Although the container is not used for storage, the main drawback of this product is the aseptic process, short shelf
Life and refrigerator capacity.
Solution found in a ring olefin polymer (COP)
A syringe that can be disinfected at the end.
All individual components of the syringe comply with regulatory requirements, but ensure that the new product does not adversely affect patient safety or product quality.
The purpose of scienceand risk-
Based on the following strategy, COP syringes are identified as the main packaging material for high-speed production end sterilization RTA syringes (semi-)
Automatic filling and closing machine for hospital pharmacy.
Materials and methods use a 50 ml COP syringe with a polypropylene/positive Velcro tip cap and a positive Ding rubber plug with an elastic tip cap and a positive Ding rubber plug
The verification batch is salt 0.
9% the pH of phosphate buffer was 2,5.
8, 11, nac0.
9%, ethanol (IPA)
5% of water and water for injection were produced.
At t = 0, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 months, the following tests were performed on the batch;
Clarification and openness of the solution (Ph. Eur. 2. 2. 1. )
The coloring degree of the solution (Ph. Eur. 2. 2. 2)
PH value and absorbance of solution (Ph. Eur 3. 2. 2. 1)
Reducing substances (Ph. Eur. 3. 2. 2. 1)Transparency (Ph. Eur 3. 2. 2. 1)
Loss of weight, ya can see particles (Ph. Eur. 2. 9. 19)
, Silicon, closed integrity and sterility (Ph. Eur. 2. 6. 1).
Results according to Ph, all tests performed met the acceptance criteriaEur. Monographs. High pH value (11. 8)
Higher absorbance is shown, and more extracts and extracts are shown; maximum 0.
T = 06 at 24 months)
Range of pH than neutral (5–8); and maximum 0. 02.
Conclusion The syringe can be used as the main packaging material for the production of RTA products in hospital pharmacy.
Cite and/or confirm that there is no conflict of interest.
Background in order to improve the safety of medication in hospitals, the Joint Commission recommended the implementation of ready-made international standardsto-administer (RTA)drugs.
Many hospital pharmacies promote this in aseptic filling of polypropylene monomeruse syringes.
Although the container is not used for storage, the main drawback of this product is the aseptic process, short shelf
Life and refrigerator capacity.
Solution found in a ring olefin polymer (COP)
A syringe that can be disinfected at the end.
All individual components of the syringe comply with regulatory requirements, but ensure that the new product does not adversely affect patient safety or product quality.
The purpose of scienceand risk-
Based on the following strategy, COP syringes are identified as the main packaging material for high-speed production end sterilization RTA syringes (semi-)
Automatic filling and closing machine for hospital pharmacy.
Materials and methods use a 50 ml COP syringe with a polypropylene/positive Velcro tip cap and a positive Ding rubber plug with an elastic tip cap and a positive Ding rubber plug
The verification batch is salt 0.
9% the pH of phosphate buffer was 2,5.
8, 11, nac0.
9%, ethanol (IPA)
5% of water and water for injection were produced.
At t = 0, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 months, the following tests were performed on the batch;
Clarification and openness of the solution (Ph. Eur. 2. 2. 1. )
The coloring degree of the solution (Ph. Eur. 2. 2. 2)
PH value and absorbance of solution (Ph. Eur 3. 2. 2. 1)
Reducing substances (Ph. Eur. 3. 2. 2. 1)Transparency (Ph. Eur 3. 2. 2. 1)
Loss of weight, ya can see particles (Ph. Eur. 2. 9. 19)
, Silicon, closed integrity and sterility (Ph. Eur. 2. 6. 1).
Results according to Ph, all tests performed met the acceptance criteriaEur. Monographs. High pH value (11. 8)
Higher absorbance is shown, and more extracts and extracts are shown; maximum 0.
T = 06 at 24 months)
Range of pH than neutral (5–8); and maximum 0. 02.
Conclusion The syringe can be used as the main packaging material for the production of RTA products in hospital pharmacy.
Cite and/or confirm that there is no conflict of interest.
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