YY 0719.3-2009 PDF English
Search result: YY 0719.3-2009_English: PDF (YY0719.3-2009)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YY 0719.3-2009 | English | 310 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Ophthalmic optics. Contact lens care products. Part 3: Microbiological requirements and test methods for products and regiments for hygienic managements of contact
| Obsolete |
BUY with any currencies (Euro, JPY, GBP, KRW etc.): YY 0719.3-2009 Related standards: YY 0719.3-2009
PDF Preview: YY 0719.3-2009
YY 0719.3-2009: PDF in English YY 0719.3-2009 (Renamed from YY 0719.3-2009)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.3-2009
Ophthalmic optics - Contact lens care products -
Part 3: Microbiological requirements and test methods
for products and regimens for hygienic management
of contact
(ISO 14729:2001, MOD)
ISSUED ON: JUNE 16, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Principle ... 4
5 Performance requirements ... 7
6 Test methods ... 9
Annex A (Informative) Test organisms from other culture collections ... 19
Annex B (Informative) Example of a membrane filtration procedure ... 20
Annex C (Informative) Technical report: Virus testing ... 23
Annex D (Informative) Technical report: Acanthamoeba testing ... 24
Annex E (Informative) Technical report: Artificial tears (organic soil) in laboratory
testing ... 25
Ophthalmic optics - Contact lens care products -
Part 3: Microbiological requirements and test methods
for products and regimens for hygienic management
of contact
1 Scope
This Part of YY 0719 specifies two test methods for evaluating the antimicrobial
activity of products to be marketed for contact lens disinfection by chemical
means and for products that are part of a contact lens care regimen.
This Part is not applicable to the hygienic management of trial lenses.
2 Normative references
The following documents contain provisions which, through reference in this
Part of YY 0719, constitute provisions of this Part. For the dated references,
their subsequent amendments (excluding corrections) or revisions do not apply
to this Part. However, the parties who enter into agreement based on this Part
are encouraged to investigate whether the latest editions of these documents
are applicable. For undated reference documents, the latest editions apply to
this Part.
YY 0719.1 Ophthalmic optics - Contact lens care products - Part 1:
Vocabulary
YY 0719.2 Ophthalmic optics - Contact lens care products - Part 2:
Fundamental requirements
3 Terms and definitions
For the purposes of this Part of YY 0719, the terms and definitions given in YY
0719.1 apply.
4 Principle
4.1 General
The stand-alone test is designed to qualify individual solutions with a suitable
level of antimicrobial activity as contact lens disinfection products. The regimen
test is designed to qualify individual solutions as part of a contact lens
disinfecting regimen. Products meeting the regimen test criteria shall also meet
the minimum performance requirements of the stand-alone test. It is
fundamental that such products (unopened containers) are capable of meeting
the requirements of the test throughout their labelled shelf life.
As described in Figure 1, contact lens care solutions which are designed to
possess disinfecting properties shall be tested in the stand-alone test first. If the
respective primary criteria are met (see 5.1), the product may be labelled as a
contact lens disinfecting product. If the product fails the primary criteria of the
stand-alone test, the product must exhibit sufficient antimicrobial activity to
meet the secondary criteria of the stand-alone test as listed in 5.2. If these
secondary criteria are met, the regimen test shall be performed in order to
qualify the product as part of a contact lens disinfecting regimen by meeting the
regimen criteria (see 5.3). If the product meets both the secondary criteria of
the stand-alone test and the regimen test but fails the primary criteria of the
stand-alone test, it shall be labelled as part of a contact lens disinfecting
regimen.
The design of contact lens care products for cleaning and contact lens
disinfection shall take into consideration the needs of patient compliance and
the probability of non-compliance. For example, disinfecting time must be
appropriate for contact lens wear.
Note: Use of multiple or mixed microbial challenges can influence the apparent disinfecting
activity of a particular product. The evaluation of these variables together with testing
against a larger panel of microorganisms and testing of samples from partially used
containers may be of value in developing a contact lens care product but are
excluded from the scope of this Part.
4.2 Stand-alone test (inoculum challenge test)
The stand-alone test challenges a disinfecting product with a standard inoculum
of a representative range of microorganisms and establishes the extent of their
viability loss at pre-determined time intervals comparable with those during
which the product may be used. The size of the microbial challenge chosen in
this test is not intended to be representative of the likely challenge in practice
but to provide countable numbers from which estimation of the rate and extent
of viability loss can be determined.
In carrying out the test for antimicrobial activity the qualitative and quantitative
compositions of the product have to be known at the time of testing by either
analytical testing or extrapolation.
performance requirements for the stand-alone test may be incorporated into a
disinfecting regimen.
In carrying out the antimicrobial activity test, qualitative and quantitative
composition of all products used in the test regimen have to be known at the
time of testing, either by analytical testing or extrapolation.
Appropriate measures shall be taken to inactivate or remove residual
antimicrobial activity during culturing and counting of challenge organism
survivors, and the effectiveness of these measures shall be validated. The
action of this process during the test shall be demonstrated by the construction
of suitable controls.
Note: For problems associated with the use of human-worn lenses, see annex E.
5 Performance requirements
5.1 Stand-alone test: Primary criteria (see also Table 1)
5.1.1 Bacteria
The number of each challenge organism recovered per millilitre shall be
reduced by an average value of not less than 99.9 % (3.0 logs) within the
minimum recommended soaking period.
Note: The value is determined by taking the average of the log reductions for each
challenge organism for the individual lots tested.
5.1.2 Moulds and yeasts
The number of each challenge organism recovered per millilitre shall be
reduced by an average value of not less than 90 % (1.0 log) within the minimum
recommended soaking period with no increase at not less than four times the
minimum recommended soaking period within an experimental error of ± 0.5
logs.
Note: The value is determined by taking the average of the log reductions for each
challenge organism for the individual lots tested.
5.2 Stand-alone test: Secondary criteria (see also Table 1)
Products failing to meet the criteria in 5.1.1 or 5.1.2 shall be evaluated by the
regimen test procedure described in 6.4, provided the sum of the averages is a
minimum of 5.0 log units reduction for the three species of bacteria within the
recommended soaking period with a minimum average of 1.0 log unit reduction
for any single bacteria. Stasis for the yeast and mould shall be observed for the
The following common laboratory equipment is required.
6.1.3.1 Sterile pipettes.
6.1.3.2 Swabs.
6.1.3.3 Tubes.
6.1.3.4 Petri dishes (90 mm to 100 mm × 20 mm).
6.1.3.5 Incubator.
6.1.3.6 Spectrometer, for determination of cell density.
6.1.3.7 Instrument for colony counting.
6.1.3.8 Centrifuge.
6.1.4 Test samples
The product to be tested shall be representative of the product to be marketed.
Aliquots should be taken directly from the final product container immediately
prior to testing.
Three lots of samples shall be tested with each prepared inoculum.
6.1.5 Culture maintenance
Maintain the test cultures as recommended by the curator of the appropriate
culture collection.
Cultures should be no greater than 5 passes removed from the depository stock
(ATCC, NCIB, NCTC, NCPF or other recognized culture depository; see annex
A). Each pass is a subculture of the previous pass.
6.2 Preparation of microbial challenge (inoculum)
The preparation of the microbial challenge organisms (inoculum) is common to
both the stand-alone test procedure and the regimen test procedure.
For the regimen test procedure, organic soil may be included as part of the
inoculum. See annex E for an example.
Culture each test organism on agar slopes under the conditions given in Table
3.
Inoculate the sample tube of a suspension of test organisms sufficient to
provide a count of between 1.0 × 105 and 1.0 × 106 CFU/ml. Ensure that the
volume of inoculum does not exceed 1 % of the sample volume. Ensure
complete dispersion of the inoculum by adequate mixing.
6.3.1.2 Store the inoculated product at 20 °C to 25 °C. The temperature shall
be monitored and the temperature documented.
If the product is sensitive to light it should be protected during the period of the
test.
6.3.1.3 Take 1.0 ml aliquots of the inoculated product for determination of viable
count at 25 %, 50 %, 75 % and 100 % of the minimum recommended
disinfecting time for all organisms, and, in addition, not less than 400 % of the
minimum recommended disinfecting time for yeast and mould. If overnight
contact lens disinfection is recommended, use a soaking time of 8 h.
6.3.1.4 Subject each of the 1.0 ml aliquots, removed at the specified time
intervals, to a suitable series of decimal dilutions in validated neutralizing media.
Mix the suspension well by vortexing vigorously and let stand to allow
neutralization to be completed. Neutralization conditions shall be based on
recovery medium control testing (see 6.3.2.2).
If an antimicrobial agent in the formulation cannot be adequately inactivated or
neutralized, eliminate it using a validated membrane filtration procedure (see
annex B).
6.3.1.5 Determine the viable count of organisms in appropriate dilutions by
preparation of triplicate plates (unless otherwise justified) of a suitable recovery
medium (e.g. TSA for bacteria, SDA for yeast and PDA for mould).
If membrane filtration has been employed to remove or neutralize antimicrobial
agents, culture the membranes on these media as appropriate.
If the pour plate method is utilized, keep the agar below 50 °C prior to pouring.
The agar media used for determination of viable counts may also contain
antimicrobial inactivators or neutralizers, if required.
6.3.1.6 Incubate bacterial recovery plates at 30 °C to 35 °C. Incubate yeast
recovery plates at 20 °C to 25 °C or 30 °C to 35 °C. Incubate mould recovery
plates at 20 °C to 25 °C. Incubation times for optimal recovery of bacteria, yeast
and moulds shall be determined. Minimum incubation times shall be based on
recovery medium control testing (see 6.3.2). Record the number of CFU
observed on countable plates.
organism.
If a dilution of greater than 1/10 is required for neutralization, then membrane
filtration shall be used.
Validate the neutralization of the product with each challenge organism initially
and as appropriate.
6.3.2.3 Control specification
If any control value is outside that specified, repeat the procedure as the
associated test is invalid.
6.3.3 Test report
The test report shall specify:
a) reference to this Part;
b) the identification of the product:
- name of the product;
- batch number;
- expiry date;
- manufacturer;
- storage conditions;
- active substances(s) and its/their concentration(s) (as available);
c) the name/s of the operator/s;
d) deviations from the protocol;
e) period of incubation;
f) storage time for inoculated product;
g) results obtained.
If a product passes the primary criteria of the stand-alone test, it may be labelled
as a contact lens disinfecting product. If the product only passed the secondary
criteria of the stand-alone test, and the regimen test, it shall be labelled as part
of a contact lens disinfecting regimen.
6.4 Regimen procedure
6.4.3.6 Incubate bacterial recovery plates at 30 °C to 35 °C. Incubate yeast
recovery plates at 20 °C to 25 °C or 30 °C to 35 °C. Incubate mould recovery
plates at 20 °C to 25 °C. Incubation times for optimal recovery of bacteria, yeast
and moulds shall be determined. Minimum incubation times shall be based on
recovery medium control testing (see 6.4.4). Record the number of CFU
observed on countable plates. Plates should be observed periodically during
incubation to prevent the occurrence of uncountable plates due to overgrowth.
6.4.4 Controls
6.4.4.1 Lens inoculation control
For each microbial species tested, transfer three inoculated lenses to tubes of
a suitable diluent (e.g. DPBST). Vortex for 30 s. Serially dilute and plate out
appropriate dilutions in triplicate (unless otherwise justified) to permit a count of
viable cells present. This count confirms that the number of organisms on the
lens at the time of the regimen challenge is adequate. The mean of the counts
should be not less than 2 × 105 CFU/lens and not greater than 2 × 106 CFU/lens.
6.4.4.2 Recovery medium control
Prepare filtration apparatus in triplicate (unless otherwise justified) as described
in 6.4.3 with suitable volumes of the neutralizing medium and disinfecting
product (see annex B). Let it stand to allow neutralization to be completed. Add
5 CFU to 100 CFU challenge organisms (one organism per filter), filter and
cultivate as described in 6.4.3.
Confirm the inoculum on a suitable medium in triplicate (unless otherwise
justified).
Ensure that the recovery on the filter from the neutralizer broth is at least 50 %
of the inoculum.
Validate the neutralization of the product with each challenge organism initially
and as appropriate.
6.4.5 Test report
The test report shall include:
a) reference to this Part;
b) the identification of the product:
- name of the product;
- batch number;
Annex B
(Informative)
Example of a membrane filtration procedure
B.1 Materials and reagents
B.1.1 Culture media and reagents
B.1.1.1 Diluting fluid, with or without neutralizers.
B.1.1.2 Tryptone Soya Agar (TSA) or other suitable media.
B.1.1.3 Dulbecco's Phosphate Buffered Saline without calcium chloride and
magnesium chloride (DPBS): 200 mg/l KCl, 200 mg/l KH2PO4, 8000 mg/l NaCl,
and 2160 mg/l Na2HPO4 • 7H2O or suitable diluent.
B.1.1.4 Dulbecco's Phosphate Buffered Saline plus 0.05 % polysorbate-80
(DPBST) or suitable diluent.
B.1.1.5 Validated neutralizing agents/media, as required, for example, Dey-
Engley Neutralizing Broth (DEB) and Letheen Broth.
B.1.2 Test equipment
Usual laboratory equipment (such as sterile pipettes, Petri dishes, containers)
together with the following.
B.1.2.1 Sterile apparatus for holding the sterile membrane filter and filtrate.
B.1.2.2 Equipment for creating a vacuum or pressure to cause the inoculated
test solution to pass through the membrane filter aseptically.
The membrane filter should have a pore size of not greater than 0.45 μm, a
diameter of at least 47 mm and should be free of chemicals which could be
toxic to microbial cells.
B.2 Test method and results
B.2.1 Moisten the sterile membrane filter in a sterile filter assembly (B.1.2.1)
with sterile DPBST (B.1.1.4) or suitable diluent.
B.2.2 Aseptically transfer a measured volume of the inoculated test solution
into 50 ml to 100 ml of sterile DPBST (B.1.1.4) or diluting fluid and thoroughly
Annex C
(Informative)
Technical report: Virus testing
Due to fundamental differences in life forms, viruses do not replicate and
proliferate on contact lenses, in lens cases, or in lens care solutions the way
gram-negative bacteria such as Pseudomonas and Serratia or Acanthamoeba
can. This is because viruses are obligate intracellular parasites and require
living cells in which to multiply. The mode of transmission of viral keratitis
caused by Herpes simplex usually occurs in childhood and 80 % of the
population have already been infected with Herpes simplex by the age of 15.
Recurrent infection in adults is triggered by stress, fever or UV light because of
the reactivation of the latent virus already present in nerves and other tissues.
Transferring the infection from one body site to another is possible.
There is a risk of measurable transmission of viruses, such as HIV, hepatitis or
adenovirus from trial lenses in the practitioner's office, because the virus can
be associated with the surface of the lens. A literature search showed that no
reports were found which implicated transmission of viruses by contact lenses
for individual use or a direct association between contact lens wear and viral
infections of the outer eye.
This Standard is intended to provide a means for the evaluation of contact lens
disinfecting systems for individual use only. Since incidents of viral transmission
via contact lens wear have not been documented and viruses cannot proliferate
on contact lenses or in lens cases, this Standard does not recommend virucidal
testing.
In the event of a viral ocular infection during a period of contact lens wear, it is
recommended that the contact lenses and the contact lens case be discarded
to avoid the possibility of reinfection.
Annex E
(Informative)
Technical report: Artificial tears (organic soil) in laboratory testing
Organic soil is not required for evaluation of contact lens disinfecting products
but may be used; this informative annex is included to discuss organic soil in
the context of contact lenses and contact lens care products.
It has been established that the presence of organic material may affect the
microbicidal activity of some contact lens disinfecting products. In the regimen
test, organic soil may be added to the lenses to mimic deposits that may be
present in actual patient use situations. Inclusion of organic load allows for an
evaluation of the cleaning step to remove debris and associated
microorganisms, as well as the interaction of any remaining organic material
with the soaking solution.
There have been numerous attempts to develop and standardize an artificial
tear model, or organic soil, for use in evaluating contact lens care products. The
intent was to imitate or mimic the natural tear fluid; however, no model
completely represents the very complex characteristics of human tears or a
natural tear film on a contact lens.
The tear film is composed of a superficial lipid layer, an aqueous phase and a
mucous layer. The aqueous phase contains at least 60 protein components,
including lysozyme, lactoferrin, tear lipocalin, transferrin, albumin,
caeruloplasmin, complement, glycoproteins, antiproteinases and a variety of
immunoglobulins; specifically, secretory IgA. Although many laboratory artificial
tear or organic soil models are available none of these contain all the
components found in natural tears. Furthermore, tear component
concentrations, activity and sources (e.g. egg-white compared with human
lysozyme) in artificial models do not fully correlate with human tears.
In addition to tear component composition, several additional factors need to
be considered when attempting to simulate a natural tear film. The composition
of human tears is variable in time and from individual to individual. More
importantly, once tears are absorbed onto a lens, the activity of the tear film
may be dissimilar to its original activity.
Additional inconsistencies may be found when depositing artificial tears onto
the lens surface:
a) the nature and composition of a macromolecular film on a lens will depend
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|