ISO 13212:2011 pdf free

ISO 13212:2011 pdf free.Ophthalmic optics – Contact lens care products – Guidelines for determination of shelf-life
The various test conditions should be stated. Depending on the nature and objectives of the stability study, the following points may need to be considered:
a) Various test temperatures: three or more, particularly if long-term real-time data are unavailable. In addition, the effect of low temperatures may need to be considered, such as below -15°C(freezer), 2°C to 8 °C (refrigerator) and freeze-thaw cycling.
b) High humidity: relative humidity > 75 %. Storage under high humidity conditions applies particularly to solid dosage forms. For products such as solutions, suspensions, etc. contained in packs designed to provide a permanent barrier to water loss, storage under high humidity is not necessary. However, low humidity can have an adverse effect on products packaged in semi-permeable containers.
c) Elevated temperature and humidity in combination: e.g. temperature of 40°C associated with a relative humidity of 75 %, possibly with the effects of cycling between different temperatures and humidities.
d) Since most contact lens care products are water based, relative humidity less than 40 % should be considered: for example, 25°C and 35 % relative humidity.
e) Light: either natural daylight or defined artificial ilumination.
An example of a stability testing plan for the finished product is shown in Annex A.
The number of batches tested shall be stated with the batch number, details of the composition, date of manufacture, size of the batch, and the batch number and the name of the manufacturer of the active ingredient(s) used.
Normally, three batches of the finished product are studied. If the number of batches tested is less than three, it shall be justified.
Satisfactory performance of the product in the smallest size of container with the highest surface/volume ratio shall allow the extension of sel-life to containers which are up to eight times larger in volume.
The product batches shall be packed in the primary containers proposed for marketing. The smallest primary container size should be tested. Satisfactory performance in the smallest size shall allow marketing of the product in containers with eight times the volume present in the smallest size.ISO 13212 pdf download.