Agar Strips LAC y [Pack of 40]

Description

HYCON® Agar Strips LAC-Y are ready-to-use culture media for assessment of airborne microorganisms with HYCON® Microbial Air Samplers, i.e. RCS® High Flow Touch, RCS® High Flow, RCS® Plus, RCS® Plus Ex, RCS® Standard, and RCS® Isolator in controlled clean room environments of production lines for beta-lactam antibiotics, i.e. grade A and B cleanrooms, RABS or isolators.

Each agar strip is individually sealed in the transparent and flexible primary backing film made from PET. The individually sealed film is double bagged in PP/PA/PA bags and gamma-irradiated at a dose of 16-27 kGy within the polystyrene box.

The formulation of the basic medium (Soybean-Casein Digest Agar) complies with the recommendations of the current European, Japanese and United States Pharmacopoeia and is supplemented with neutralizers and a mixture of a broad spectrum Cephalosporinase (beta-lactamase II) and Penase (beta-lactamase I).

Mode of Action
Tryptic Soy Agar (TSA, Soybean Casein Digest Agar) is a complex medium for cultivation and isolation of a wide range of bacteria, yeasts and molds. The medium is supplemented with the neutralizers lecithin and polysorbate 80.
The included beta-lactamase mixture of Cephalosporinase and Penase shows inactivating properties towards a wide variety of penicillins, cephalosporins from the 1st to the 5th generation as well as carbapenems and monobactams.
The neutralizing efficiency towards present residues of beta-lactam antibiotics should be validated at the sampling site.

Typical Composition
Pancreatic digest of casein: 15 g/l
Soy bean peptone: 5 g/l
NaCl: 5 g/l
Cephalosporinase: 1 000 I.U./l

Penicillinase: 10 000 I.U./l

Agar: 15 g/l

Neutralizers: lecithin, polysorbate 80

Supplements such as buffer

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

Application and Interpretation

The agar strips are introduced into cleanrooms grade A or B by removing one bag in each material lock. Prior to use the agar strip should be equilibrated to room temperature. Please check each agar strip before use to verify sterility and take care on aseptic handling in order to avoid false positive results. Contaminated or dehydrated agar strips should not be used for sampling.

Open the wrapper approximately at 1/3 by pealing back the plastic seal at the rounded side of the wrapper.

Remove the agar strip with the coated side facing downwards. Insert the agar strip into the opening of the rotor, or the impeller drum according to the directions outlined in the user manual of the respective microbial air sampler.

Place the instrument into required position, choose the appropriate sample volume and start the air sampling procedure. When sampling is finished, remove the agar strip and place it back into the original wrapper. Seal the wrapper with the cover slide.

Label the wrapper e.g. with a waterproof pen for identification. The closed agar strips are transferred to an incubator.

Several recommendations are given by different guidelines for incubation: according to USP <1116> the agar media used for environmental monitoring should be incubated between 20 and 35 °C for not less than 72 hours.

According to the FDA Aseptic Guide the agar strips for determination of the total aerobic bacterial count should be incubated at 30 to 35 °C for 48 to 72 hours, while the agar strips for determination of the total yeast and mold count should be incubated at 20 to 25 °C for 5 to 7 days. Individual incubation conditions can be chosen and should be validated at the application site.

Finally, the number of CFU per slide is examined. Grown colonies may be identified using suitable methods related to root cause analysis programs or to support sanitizing management.

Important Notes

• Practice aseptic technique when handling agar strips.

• The coated surface of the agar strips should face down during incubation in order to avoid the formation of satellites by condensing water.

Storage
The product can be used until the expiry date if stored in the original box, protected from light and properly sealed at the temperature range indicated on the box label. The total shelf from the date of production is 6 months.

Condensation can be prevented by avoiding quick temperature shifts and mechanical stress. Upon storage agar strips should not be placed near heat sources such as refrigerators with heat-emitting condensers. Boxes should be stored with the coated side of the agar strip facing downwards.

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.).

HYCON® Agar Strips are used for monitoring of ambient air and compressed gases with the RCS® High Flow Touch Microbial Air Sampler and the RCS® Isolator. They are also applied with the RCS® Standard and the RCS® Plus Ex Microbial Air Sampler for monitoring of explosion hazard areas.

Reliable quality:

• Manufactured under strictly controlled aseptic conditions
• Fully validated according to ISO 14698-1/2 in combination with RCS® Systems
• Also available as gamma-irradiated consumables in sterile double packaging for use in critically controlled areas

Safe and convenient:

• Re-sealable sleeve ensures sterility and allows for secure handling
• Individually packed and 100% visually checked
• Validated storage from 2-25 °C, thus allowing room temperature storage (except agar strips S and C)
• Shelf life of up to six months: saves costs when fewer incoming goods controls are needed

Flexible:

• Available as total count media and selective media: adapts to, depending on user requirements

Additionally, for gamma-irradiated products:

• Gamma-irradiated for maximum safety
• Specifically designed for applications within isolator and clean room environments
• Double packaging allows for easy transfer into critical areas
• Contained additives for neutralization of more than 5,000 ppm of hydrogen peroxide (only TCI- γ)