ICR Swabs [Pack of 100]

Description

ICR Swabs are designed for environmental monitoring of  dry surfaces e.g. filling needles, tubing or other hardly to  assess surfaces in cleanrooms and isolators. The principle of the test system is a qualitative presence/absence test for microbiological contamination on the tested surface.

The ICR Swabs are triple bagged and gamma-sterilized in the final packaging at a dose of 25-35 kGy. The primary and secondary sleeves consist of a multilayer material including PET and LLDPE.
The formulation of the basic medium (SoybeanCasein Digest Medium) is prepared according to the recommendations of the current European, Japanese and United States Pharmacopoeia (EP, 2.6.1. and USP,
71) and supplemented with polysorbate (Tween®) 80, lecithin and pyruvate.

Mode of Action
The ICR-Swab is an all in one sample system for swabbing the surface, rinsing and incubating the swab by opening the system only once.
The ICR-Swab is based on a dual chamber system. One chamber contains the tube with the pre-moisturized swab, the second bulb chamber contains a soybeancasein digest medium supplemented with polysorbate (Tween®) 80, lecithin and pyruvate.

Both chambers are connected by the hollow shaft of the swab which is closed prior to sampling. By snapping the
upper bulb chamber this closure is opened. Afterwards the culture medium can be squeezed to the swab tip.

The Swab is designed to provide the highest degree of safety for critical environments. To apply the swab, the sample system must be opened only once for swabbing the surface. All further steps such as rinsing the swab with the growth medium as well as incubation and examination are performed completely in the closed system. This assembly reduces the risk of secondary contamination by unnecessary handling.

Each ICR-Swab is labelled with the name of the product, lot number and shelf life data. Further-more the label can be imprinted with further information such as site of sampling, sampling date etc. Each tube label is provided
with an individual 22-digit 2D data matrix code (digits1-3: product code = 529; digits 4 to 9 = batch number;
digits 10 to 17 = expiry date (YYYY/MM/DD); digits 18 to 22: individual swab number within batch.

The ICR-Swabs are triple-bagged and gamma-sterilized at a dose of 25-35 kGy in the final packaging. Each
single swab is bagged in non-transparent, hydrogen peroxide impermeable sleeve. 10 single bagged ICRSwabs are combined in a second non-transparent, hydrogen peroxide impermeable sleeve, which is labelled with product name, article number, lot number, expiry date, and storage temperature. These bags contain a tear notch for easy opening. A third transparent sleeve is sealed around the second layer.

The swab tip is made from knitted polyester, which minimizes the generation of particles. The swab is premoistened with 150 µL 0.9 % sodium chloride solution for swabbing dry surfaces. The moistening liquid does not contain any nutrients and neutralizing agents to protect the swabbed surface from a release of any growth promoting residues.

Typical Composition

Growth Medium in Bulb Reservoir (2 mL)
Casein Peptone 17 g/L
Soy Peptone 3 g/L
Glucose Monohydrate 2.5 g/L
K2HPO4 2.5 g/L
NaCl 5 g/L
Polysorbate (Tween®) 80 10 mL/L
Lecithin 1 g/L
Swab-Tip: Pre-Moistening Solution (0.15 mL)
NaCl 9 g/L

The appearance of the growth medium is clear and yellowish. The pH value is in the range of 7.1 – 7.5. The medium can be adjusted and/or supplemented according to the performance criteria required.

Application and Interpretation
The triple packaging allows a safe transfer into the cleanrooms up to Grade A as well as into isolators.
Each bag can be removed per material lock before entering the next higher cleanroom environment. The outer bag must be opened using a scissor, while the middle and inner bag can be opened easily at the tear notch. The middle and inner bag are VHP impermeable and provided with a hole for hanging them up in an isolator during VHP decontamination.

According to ISO 14698 the swab should be stroked in close parallel sweeps over the defined sampling area, while being slowly rotated. Sampling of the same area should be repeated, stroking the same swab perpendicular to the initial sweep.
After sampling the broth medium is squeezed into the tube. Used swabs should be transported and incubated
in an upright position, e.g. by making use of aswab rack.
The ICR Swabs are gamma-sterilized at a dose of 25 to 35 kGy with a validated SAL of 10-6. Please check
the broth medium within the tube immediately after sampling and before starting incubation. Turbid broth media must not be used for incubation and examination to avoid false positive results.

The TSB is supplemented with lecithin and polysorbate (Tween®) 80 to resurrect damaged organisms and to
neutralize residues of several disinfectants. Grown microorganisms out of turbid culture media should be identified.

Storage and Shelf Life
The product can be used for sampling until the expiry date if stored protected from light and properly sealed at +2 °C to +25 °C.
The testing procedures as described on the CoA can be started up to the expiry date printed on the label.

Disposal
Please mind the respective regulations for the disposal of used culture medium (e.g. autoclave for 20 min at 121 °C, disinfect, incinerate etc.).