SANS 598-2008 Sterilized dextrose intravenous infusion《无菌葡萄糖静脉输液》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-20997-1 SANS 598:2008Edition 5 SOUTH AFRICAN NATIONAL STANDARD Sterilized dextrose intravenous infusion Published by Standards South Afric

4、a 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 598:2008 Edition 5 Table of changes Change No. Date Scope Foreword This South African standard was approved by National Committee

5、StanSA SC 5140.36A, Intravenous solutions, injectables and infusion sets Intravenous solutions and injectables, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This document was published in February 2008. This document supersedes SABS 59

6、8:1987 (third revision). A reference is made in 6.2.1(m) to labelling required by “the current relevant national legislation“. In South Africa this means the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965). Annex A forms an integral part of this standard. Annex B is for info

7、rmation only. SANS 598:2008 Edition 5 1 Contents Page Foreword 1 Scope . 3 2 Normative references. 3 3 Definitions 3 4 Requirements. 4 4.1 Freedom from visible suspended matter and sediment 4 4.2 Fill volume. 4 4.3 pH value 4 4.4 Identification of dextrose 4 4.5 5-Hydroxymethylfurfural and related s

8、ubstances . 4 4.6 Dextrose content. 4 4.7 Particulate matter (sub-visible particles). 4 4.8 Sterility 4 4.9 Bacterial endotoxins . 4 5 Inspection and methods of test 5 5.1 General . 5 5.2 Inspection 5 5.3 Fill volume. 5 5.4 pH value 5 5.5 Identification of dextrose. 5 5.6 5-Hydroxymethylfurfural and

9、 related substances . 6 5.7 Dextrose content. 6 5.8 Particulate matter (sub-visible particles). 7 5.9 Sterility 7 5.10 Bacterial endotoxins . 7 6 Packing and marking . 7 Annex A (normative) Sampling and compliance with this standard. 10 Annex B (informative) Quality verification of sterilized dextro

10、se intravenous infusion. 11 Bibliography. 11 SANS 598:2008 Edition 5 2 This page is intentionally left blank SANS 598:2008 Edition 5 3 Sterilized dextrose intravenous infusion 1 Scope This standard covers chemical and biological requirements for a solution of dextrose in water for injections that ha

11、s been dispensed into suitable containers, sealed and sterilized. It also specifies the required marking. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, th

12、e latest edition of the referenced document (including any amendments) applies. Information on currently valid national and international standards can be obtained from Standards South Africa. 2.1 Standards SANS 1384, Plastics containers for parenteral solutions. SANS 3696/ISO 3696, Water for analyt

13、ical laboratory use Specification and test methods. 2.2 Other publications British Pharmacopoeia (BP). United States Pharmacopeia (USP). 3 Definitions For the purposes of this document, the following definitions apply. 3.1 acceptable acceptable to the authority administering this standard, or to the

14、 parties concluding the purchase contract, as relevant 3.2 batch that quantity of the product that is homogenous, filled and sealed in containers, and sterilized in the same cycle of operations 3.3 product dextrose intravenous infusion that is filled, sealed and sterilized in the final container SAN

15、S 598:2008 Edition 5 4 4 Requirements 4.1 Freedom from visible suspended matter and sediment When examined in accordance with 5.2, the product shall be clear and colourless and shall not contain any antimicrobial agents nor any other added substances. Solutions containing 200 g or more of dextrose p

16、er litre shall not be more than faintly straw-coloured. 4.2 Fill volume 4.2.1 The maximum nominal fill volume of a container shall not exceed 1 L. 4.2.2 When determined in accordance with 5.3, the volume of the contents of each container shall not be less than the nominal volume and not more than 11

17、0 % of the nominal volume. 4.3 pH Value When determined in accordance with 5.4, the pH value of the product shall be between 3,5 and 6,5. 4.4 Identification of dextrose When tested in accordance with 5.5, the product shall give a positive reaction for dextrose. 4.5 5-Hydroxymethylfurfural and relate

18、d substances When tested in accordance with 5.6, the absorbance of the diluted product solution shall not exceed 0,25. 4.6 Dextrose content When determined in accordance with 5.7, the dextrose (C6H1206) content of the product shall be between 95,0 % and 105,0 % of the concentration stated on the con

19、tainer or on the label. 4.7 Particulate matter (sub-visible particles) When tested in accordance with 5.8, the number of particles with a diameter 10 m and 25 m, respectively, shall comply with the limits for small volume injections and large volume injections, as relevant. 4.8 Sterility When tested

20、 in accordance with 5.9, there shall be no signs of microbial growth. 4.9 Bacterial endotoxins When tested in accordance with 5.10, the product shall not contain more than 0,5 USP Endotoxin Units per millilitre for infusions containing less than 5 % of dextrose and not more than 10,0 USP Endotoxin U

21、nits per gram for infusions containing between 5 % and 70 % of dextrose. SANS 598:2008 Edition 5 5 5 Inspection and methods of test 5.1 General Unless otherwise specified, only use water that complies with the requirements for grade 3 water as given in SANS 3696, and reagents of analytical reagent g

22、rade or of the purest grade available. 5.2 Inspection 5.2.1 Gently invert the container and examine, without magnification, for any visible signs of suspended matter or sediment (see A.3). 5.2.2 Check for compliance with 4.1. 5.3 Fill volume 5.3.1 Transfer, as completely as possible, the contents of

23、 a container into a graduated measuring cylinder of a size able to contain at least 110 % of the nominal volume of the container. 5.3.2 Record the volume of liquid in the measuring cylinder. 5.3.3 Determine the average fill volume of at least three containers. 5.3.4 Check for compliance with 4.2. 5.

24、4 pH value 5.4.1 Dilute the product with water for injections or grade 3 water that complies with SANS 3696, if necessary, to contain not more than 5 g of dextrose per 100 mL. 5.4.2 Determine the pH value in accordance with the relevant procedure described in the current BP. 5.4.3 Check for complian

25、ce with 4.3. 5.5 Identification of dextrose 5.5.1 Reagents 5.5.1.1 Solution A Dissolve 3,466 g of cupric sulfate (CuSO45H2O) in water and dilute to 50,0 mL with water. 5.5.1.2 Solution B Dissolve 17,3 g of crystalline potassium sodium tartrate (KNaC4H4O64H2O) and 5 g of sodium hydroxide in water and

26、 dilute to 50,0 mL with water. 5.5.1.3 Cupric-tartaric solution Mix equal volumes of solution A and solution B immediately before use. SANS 598:2008 Edition 5 6 5.5.2 Procedure 5.5.2.1 Heat 5 mL of the cupric-tartaric solution in a test tube. Add a few drops of the product and heat again if necessar

27、y. 5.5.2.2 A copius red precipitate indicates the presence of dextrose. 5.5.2.3 Check for compliance with 4.4. 5.6 5-Hydroxymethylfurfural and related substances 5.6.1 Dilute a volume of the product containing 1,0 g of dextrose (C6H12O6) to 250,0 mL with water. 5.6.2 Measure the absorbance of this s

28、olution at the maximum at approximately 284 nm in a 1 cm cell with water in the reference cell. 5.6.3 Check for compliance with 4.5. 5.7 Dextrose content 5.7.1 Apparatus Polarimeter, capable of giving readings to the nearest 0,01. 5.7.2 Reagent Ammonia solution, 5 M Dilute 37,5 mL of concentrated am

29、monia (about 13,5 M) to 100,0 mL with water. 5.7.3 Procedure 5.7.3.1 Pipette a volume of the product containing 2 g to 5 g of dextrose into a 100,0 mL volumetric flask. 5.7.3.2 Add 0,2 mL of the ammonia solution and dilute to 100,0 mL with water. Mix well and leave for 30 min. 5.7.3.3 Determine the

30、optical rotation (R) at (20 0,5) C in a 200 mm tube with the polarimeter using sodium light. 5.7.3.4 Calculate the dextrose content (D) of the product, in g/100mL, using the following formula D = VR 1000,9477 where R is the observed optical rotation, in degrees; V is the volume of the product used f

31、or the test, in millilitres. SANS 598:2008 Edition 5 7 The observed rotation multiplied by 0,9477 represents the mass of dextrose (C6H12O6), in grams, in the volume (V) used for the test. 5.7.3.5 Check for compliance with 4.6. 5.8 Particulate matter (sub-visible particles) 5.8.1 Use the method under

32、 “Light obscuration particle count test“ given in the USP. 5.8.2 Check for compliance with 4.7. 5.9 Sterility 5.9.1 Use the method under “Sterility tests“ given in the USP. 5.9.2 Check for compliance with 4.8. 5.10 Bacterial endotoxins 5.10.1 Use the method under “Bacterial endotoxins test“ given in

33、 the USP. 5.10.2 Check for compliance with 4.9. 6 Packing and marking 6.1 Packing 6.1.1 Containers 6.1.1.1 The product shall be dispensed in acceptable, clean, single-dose, colourless containers that shall not affect or be affected by the contents. 6.1.1.2 Glass containers shall be transparent and s

34、hall be of type I or type II glass as described under “Glass containers for pharmaceutical use“ in the BP. Plastics containers shall comply with the requirements of SANS 1384. 6.1.1.3 Containers shall be hermetically closed by means of suitable closures that shall not affect or be affected by the co

35、ntents of the container. 6.1.2 Packages An acceptable number of containers of the same batch identification shall be packed together in a package of suitable design that is sufficiently robust to protect the contents during normal handling, transportation and storage. 6.1.3 Bulk packs An acceptable

36、number of packages of the same batch identification shall be packed in a bulk pack that is sufficiently robust to protect the contents during normal handling, transportation and storage. SANS 598:2008 Edition 5 8 6.2 Marking 6.2.1 Containers The following information shall appear in clear and indeli

37、ble marking on each container, or on a label securely affixed to the container, in at least English: a) the approved name of the product; b) the nominal volume of the contents; c) the concentration of the dextrose, expressed as a percentage (mass volume fraction) or the mass in grams per the nominal

38、 volume of the contents; d) the batch identification, prefixed by the word “LOT“; e) the expiry date by year and month; where only numerals are used to indicate the date, the year shall be given in four digits; f) the trade name or trademark of the manufacturer; g) recommended storage conditions, if

39、 any; h) the word “Sterile“; i) the route of administration; j) the approximate concentration of the ions present, expressed as millimoles per litre; k) a warning that the contents are not to be used if the product contains visible solid particles or is not clear, or if the container or closure is n

40、ot intact; l) the full business address of the manufacturer; and m) the registration number, schedule number and any other labelling required by the current relevant national legislation (see foreword). NOTE The marking requirements given in 6.2.1(h) to 6.2.1(m) may be omitted from containers that a

41、re too small to bear all the marking specified in 6.2.1. 6.2.2 Packages The following information shall appear in clear and indelible marking on each package, or on a label securely affixed to the package, in at least English: a) the information required in 6.2.1(a) to 6.2.1(h) (inclusive); b) the f

42、ull business address of the manufacturer; and c) the number of containers in the package. SANS 598:2008 Edition 5 9 6.2.3 Bulk packs The following information shall appear in clear and indelible marking on each bulk pack, or on a label securely affixed to the bulk pack, in at least English: a) the i

43、nformation required by 6.2.1(a) to 6.2.1(f) (inclusive); b) the full business address of the manufacturer; and c) the number of packages in the bulk pack. SANS 598:2008 Edition 5 10 Annex A (normative) Sampling and compliance with this standard A.1 Sampling A.1.1 General The following sampling proce

44、dure shall be applied in determining whether a lot submitted for inspection and testing complies with the relevant requirements of this standard. The sample so drawn shall be deemed to represent the lot. A.1.2 Definitions A.1.2.1 defective sample that fails in one or more respects to comply with the

45、 relevant requirements of this standard A.1.2.2 lot not less than 100 containers of the same type and nominal volume, bearing the same batch identification, from one manufacturer, and submitted at any one time for inspection and testing A.2 Sample for testing A.2.1 Chemical tests From the lot take,

46、at random, enough containers to obtain a volume of at least 200 mL. A.2.2 Sterility test From the lot take, at random, 20 containers. A.2.3 Bacterial endotoxin test From the lot take, at random, enough containers to obtain a volume of at least 100 mL. A.3 Compliance with this standard The lot shall

47、be deemed to comply with the requirements of this standard if, after inspection (see 5.2) and testing of the samples taken in accordance with A.2, no defective is found. SANS 598:2008 Edition 5 11 Annex B (informative) Quality verification of sterilized dextrose intravenous infusion When a purchaser

48、 requires ongoing verification of the quality of sterilized dextrose intravenous infusion, it is suggested that, instead of concentrating solely on evaluation of the final product, he also direct his attention to the manufacturers quality system. In this connection it should be noted that SANS 9001 and SANS 13485 cover the provisions of an integrated quality system. Bibliography SANS 9001/ISO 9001, Quality management systems Requirements. SANS 13485/ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes. Standards South Africa