Steril C Cold Chemical Sterilant for Surgical Instruments and Endoscopes, 1 kg

Steril C is a cold chemical sterilant supplied as a fine white powder for the rapid sterilization of medical and surgical instruments, heat-sensitive or heat-stable medical devices, optical and flexible equipment, delicate plastic materials, and dental equipment. The indicated action time is 10 minutes. Steril C combines sterilization with prewashing and mechanical cleaning and is formulated without aldehydes, substances that fix proteinaceous material onto surfaces requiring sterilization. The formulation contains corrosion inhibitors and has a neutral pH that does not vary during the oxidation reaction, making it compatible with materials used in medical instruments.

Features:
• Fine white powder, supplied in a 1 kg quantity
• Cold chemical sterilant with a 10-minute action time
• Working concentration: 2%
• Aldehyde-free formulation
• Contains corrosion inhibitors and an anionic surface active agent
• Neutral pH with no variation during the oxidation reaction
• Full spectrum of activity: fungicidal, bactericidal, virucidal and sporicidal
• Working solution remains active for 48 hours regardless of the number of sterilization cycles performed
• Class IIb medical device with CE certificate and declaration of conformity

The chemical composition per 100 g of product consists of 44 g peracetic acid, 28.5 g TAED (Tetraacetylethylenediamine), as well as organic acid, anionic surface active agent, and corrosion inhibitors up to 100 g. The composition of Steril C produces a chemical reaction that forms active ingredients consisting of peracetyl ions and hydroperoxide. The anionic surface active agent provides contact with phospholipid membranes and promotes the penetration of oxidizing agents into cellular structures.

The microbiological activity of the product has been tested against several microorganisms, including Poliovirus type 1 ATCC-VR-192, Adenovirus type 5 ATCC-VR-5, Staphylococcus aureus ATCC-6538, Pseudomonas aeruginosa ATCC-15442, Enterococcus hirae ATCC-10541, Mycobacterium terrae ATCC-10541, Mycobacterium avium ATCC-15769, Candida albicans ATCC-10231, Aspergillus niger ATCC-16404, Bacillus subtilis ATCC-6633, Bacillus subtilis var. Niger CIP-7718, Bacillus cereus CIP-7803, and Clostridium sporogenes CIP-7939.

Applications:
• Medical and surgical instruments
• Rigid and flexible endoscopes, bronchoscopes, laryngoscopes, arthroscopes, cystoscopes, laparoscopes, colonoscopes and echoendoscopes
• Intraoperative probes and echocardiographic probes
• Pipes, applicators and respiratory tubing used in anesthesia
• Dental equipment and hydraulic circuits for dental units

Steril C is indicated for the cold sterilization of heat-sensitive medical materials and devices, as well as heat-stable materials. Its formulation addresses the gradual clouding of imaging equipment lenses associated with chemical sterilants and does not contain aldehydes.

Directions for use:
• Prepare a 2% working solution using 20 g of powder per 1 liter of water
• Water at 30–35°C is recommended for optimal dissolution of the powder
• Use 10 g of powder for 0.5 liters of water, 20 g for 1 liter, 50 g for 2.5 liters, and 100 g for 5 liters
• Water quality and hardness, as well as the temperature at which the solution is used, do not influence its sterilizing action
• The prepared working solution remains active for 48 hours regardless of the number of sterilization cycles performed
• Sterilant efficiency and quality can be checked using indicator test strips
• No special protective measures are required for dosing the powder

Safety instructions:
Steril C does not contain aldehydes or aldehyde derivatives. According to the supplied product information, the working solution has no toxicological restrictions and the product does not require use in ventilated rooms. All ingredients forming the Steril C formulation are 100% biodegradable, and the used working solution decomposes into water, oxygen, and acetic acid. According to the supplied information, protective equipment such as gloves, goggles, or a face mask is not required. Avoid contact with eyes, and consult a physician if ingested. The supplied information states that the product has no skin sensitizing effect and that no mutagenic or teratogenic effects have been reported in cases of prolonged skin contact.

Package contents:
• 1 x Steril C cold chemical sterilant, fine powder, 1 kg

Steril C is a Class IIb medical device intended for cold chemical sterilization of medical and surgical instruments, endoscopes, heat-sensitive equipment, and dental equipment.