BS EN 1276-2019 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas – Test method and requirements (phase 2, step 1]).
18.104.22.168 RInsing lIquid (for membrane flkratlon)
The rinsing liquid shall be validated for the product being tested in accordance with 5322.214.171.124 and 533. It shall be sterile. cwnpaUhle with the Biter membrane and capable of filtration through the filter membrane under the test condinons described in 5.53.
NOTE Information on rinsing hquids that have been found to be sultaNa’ for some categofl.s of product; is wn in Annea I).
5.22.7 Hard water for dilution of products
For (he preparation of 1 000 ml of hard water, the procedure Is as follows.
— prepare solution A: dissolve 19.84 g magnesium chloride (MgCI2) and 46.24 g calcium chloride
(CaCl) in waler (126.96.36.199) and dilute to I 000 mL Sterillte by membrane fIltration (53.2.7) or in the
autocbve (5321 a). Autocbvlng – if used may cause a loss of IIquid In this case, make up to 1
000 ml with water (188.8.131.52) under aseptic condirion. Store the solution in the refrigerator (184.108.40.206)
For no longer than one month;
— prepare solution B; dissolve 35.02 g sodium bicarbonate (NaIICO1) In waler (220.127.116.11) and dilute to 1 000 ml. Sterilize by membrane filtration (53.2.7). Store the solution In the refrigerator (18.104.22.168) for no longer than one week
— place 600 ml 10700 ml of water (52.22) In a 1 000 ml volumetric flask (5.32.12) and add 6.0 ml (53.2,9) of solution A. then 8.0 ml of solution B. Mix and dilute to 1 000 ml with water (5.2.22). The p11 of the hard water shall be 7,0 * 0,2. when nwasurcd at (20 a 1) C (5.32.4). II necessaly. adjust the pH by using a solution of approximately 40 g/l (about 1 mol/l) of sodium hydroxide (NaOtl) or approximately 36.5 gJl (about 1 mol/1) of hydrochloric arid (HCI).
The hard water shall be freshly prepared under aseptic conditions and used within 12 Ii.
When preparing the product lest solutIons (5.4.2), the addition of the product to the hard water produces a different final water hardness in each test tube. In any case, the final hardness is lower than 375 mgjl of calcium carbonate (CaCO3) in the test tube,
5.22.8 InterferIng substance
5.22 .8.1 General
The interfering substance shall be chosen according to the conditions of use laid down for the product. The interfering substance shall be sterile and prepared at 10 times its fInal concentration in the test.
The ionic composition (e.g. pH. calcium and/or magnesium hardness) and chemical composition (e.g. mineral substances, protein, carbohydrates, lipids and detergents) shall he defined.
NOTE The term loterfrring subatsaLe’ Is used even IlK cunLaUsS more than one substance.
22.214.171.124.2C1,an conditions (bovine albumin solution – low concentration)
Dissolve 0.3 got bovine albumin traction V (suitable for microbiological purposes) in 100 ml of water
Sterilize by membrane filtration (126.96.36.199), keep in the refrigerator (188.8.131.52) and use within one month. The final concentration of bovine albumin in the teat procedure (5.5) is 0.3 g/L.BS EN 1276 pdf downlaod.