Sporal A Sterilization Process Control Indicator, 10 pcs.

Sporal A – Biological Indicator for Autoclave Sterilization Control

Sporal A is a professional biological test designed to verify the effectiveness of the steam sterilization process under overpressure (in autoclaves). This tool is an essential component of sanitary control in medical and dental facilities. It minimizes the risk of bacterial and viral infections, ensuring full safety for both patients and staff.

The indicator comes in the form of a paper strip saturated with a suspension of non-pathogenic spores of the Geobacillus stearothermophilus ATCC 7953 strain, which features high thermal resistance. Each test contains a minimum of 1×105 colony-forming units (CFU). The entire strip is sealed in safe paper-foil packaging with an additional chemical indicator on the edge of the pouch that changes color when exposed to sterilization.

Technical Specification and Standards

• Manufacturer: IBSS Biomed S.A.

• Package Contents: 10 pieces of indicators

• Compliance with Standards: EN ISO 11138-1,3

• Approval: Permanent authorization No. HB/649/2000 issued by the National Institute of Hygiene (PZH)

• Storage Conditions: Store at room temperature, away from heat sources, protect from moisture

Application and Intended Use

• Places of Use: Dental, medical, and beauty clinics, tattoo studios, and all medical facilities performing the sterilization of medical devices.

• Purpose: To confirm the operational efficiency of the autoclave and to meet the strict requirements of sanitary inspectors (Sanepid).

• Frequency of Use: In accordance with the facility’s internal procedures (strictly required for every load containing implants).

Step-by-Step Instructions for Use

1. Placement: Place a minimum of two Sporal A indicators inside packaging sheets representative of the given load. Position them in the areas least accessible to steam.

2. Sterilization: Run the selected sterilization program in the autoclave.

3. Inoculation (within 2 hours): After the cycle finishes, remove the indicators from the chamber. Inoculation must be performed within 2 hours of exposure.

4. Optional Transport (within 24 hours): If immediate incubation is impossible, store the indicators at room temperature and deliver them to the laboratory within a maximum of 24 hours.

5. Control Sample: One indicator that has not been subjected to sterilization must be kept and submitted as a control sample to verify microbial viability.