BS ISO 21322 pdf free download

BS ISO 21322-2020 pdf free download.Cosmetics — Microbiology — Testing of impregnated or coated wipes and masks.
4.1 General information
The method determines the population of viable microorganisms by enumeration of colonies on a non-selective agar medium and by the presence or absence of specified microorganisms growth after enrichment.
The method involves the following steps:
— selection of the test sample;
— selection of an appropriate method;
— recovery of microorganisms;
— enumeration of the population of viable microorganisms by filtration or plate count method;
— tests for specified microorganisms by enrichment method.
The experimental conditions shall be evaluated to ensure that the method should not affect the viability of microorganisms and the recovery of bioburden from the sample and should include the verification of the efficacy of the neutralization (see Clause 11).
In order to ensure product quality and safety for the consumer, an appropriate microbiological risk assessment should be performed to determine the types of cosmetic products to which this document is applicable (see ISO 29621:2017, Table 2).
Other methods may be substituted provided that their equivalence has been demonstrated.
4.2 Selection of the test sample
— Whenever practical, the entire unit should be used for testing with a minimum weight of 1 g. If for technical reasons the entire unit cannot be tested, a defined Unit Item Portion (UIP) is used for testing. A “UIP” is a microbiologically-representative subunit of the test sample and is referenced throughout the document.
— If the unit is < 1 g per unit then the appropriate number of units should be sampled to achieve the appropriate weight or volume.
— The weight of the test sample shall be recorded even if the results are expressed by unit. Selection of the test sample shall be according to A.1.
4.3 Selection of the method The method should be conducted according to an appropriate procedure based on the specifics of the product (size, volume, single unit/multi–unit package, level of bioburden. etc.) and should ensure that a representative sample is evaluated. Selection of the method shall be according to A.1 and A.2.
4.4 Recovery of microorganisms from the test sample The degree to which microorganisms adhere to the test sample surface is dependent on the wipe or mask in which the liquid portion of the formulation has been either impregnated or coated. Preliminary treatments may be necessary to separate microorganisms from the test sample. Regardless of the treatment, the verification of recovery method should be performed in order to demonstrate that the method can release microorganisms from the test sample without having an adverse effect on their viability (see Clause 11).
4.5 Enumeration of aerobic mesophilic microorganisms
4.5.1 General
The enumeration of aerobic mesophilic microorganisms includes bacteria, yeasts and moulds.
Based on the nature of the test sample, the volume of diluent used to immerse the test sample and the expected level of bioburden, two types of counting methods may be used:
— plate count method;
— membrane filtration method.
4.5.2 Plate count method overview
Plate count method consists of either using a pour plate or spread plate method.
Each method consists of the following steps.
— Prepare the agar plates and diluent using a non-selective agar medium for plating the diluent in which the sample was immersed.
— Incubate the plates for enumeration and/or detection.
— Count the number of colonies forming units (CFU) based on the number of aerobic mesophilic microorganisms recovered per unit or g.BS ISO 21322 pdf download.