Texas Specification No. 435-04-01A
Effective Date: January 15, 1992
Reformatted Date: June 28, 1996
ANTI-MICROBIAL SOLUTION, TOPICAL, IODINE IODOPHOR COMPLEX
1. SCOPE: This specification establishes the minimum requirements for a topical skin antiseptic solution in which the active ingredient is one percent (1%) iodine. It is effective against a broad range of pathogens, providing a residual antimicrobial solution.
2. APPLICABLE SPECIFICATIONS AND STANDARDS: Reference to specifications, standards, test methods, and other documents shall be to the issues in effect on the date of the Invitation for Bids. Copies of the referenced documents may be obtained from the issuing organizations at the addresses shown. The following publications form a part of this specification to the extent specified herein.
2.1. ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS (AOAC), 2200 Wilson Boulevard, Arlington, VA 22201:
2.1.1. Official Methods of Analysis -- Fifteenth Edition 1990.
2.2. FEDERAL DOCUMENTS: Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402:
2.2.1. Code of Federal Regulations -- 16 CFR 1500: Hazardous Substances and Articles.
2.2.2. Code of Federal Regulations -- 21 CFR 333: Topical Anti-microbial Drug Products for Over-the-Counter Human Use.
3. CLASSIFICATION: The antiseptic solution shall be classified by an iodine percentage of one percent (1%).
4. DEFINITIONS: Terminology used in this specification is intended to be generic in nature and consistent with meanings that have been defined through general use and/or accepted trade practices. Where variant meanings may exist, the applicable interpretation shall be determined by the Texas Procurement and Support Services (TPASS).
4.1. Commission: Texas Procurement and Support Services (TPASS).
4.2. LD50: The probable lethal dose of undiluted product to fifty percent (50%) of the test animals, when determined for Ingestion Studies.
5. REQUIREMENTS: Products furnished under this specification shall meet or exceed the following requirements:
5.1. General Requirements: The solution shall be a non-staining, homogeneous, penetrating liquid, having an amber color (which depends on the inodophor). It shall provide non-selective action against all major classes of microorganisms, including bacteria, fungi, viruses, protozoa, and yeast, and not be inactivated by blood, pus, or serum. It shall be non-irritating, have a stable shelf life, not exhibit a flash point, and be non-combustible.
5.2. Chemical Composition: The solution shall furnish a minimum titrable iodine content of one percent (1%) by weight/volume, with sufficient iodophor to form a stable, water soluble complex. The iodophor (iodine carrier) shall be either povidone (polyvinylpyrrolidone, PVP) or a non-ionic surfactant consisting of poloxamers (block copolymers of ethylene oxide and propylene oxide) and/or oxyethylated alkylphenols. Test in accordance with Paragraph 6.1.
5.3. Anti-micorobial Effectiveness: The solution shall be miciobicidal to a broad spectrum of organisms capable of existing in or on the skin, when tested in accordance with Paragraph 6.2. The test organisms shall include the following bacterial species as a minimum:
Escherichia coli ATCC # 11229
Pseudomonas aeruginosa ATCC # 15442
Staphylococcus aureus ATCC # 6538
Mycobacterium tuberculosis var. Bovis BCG
5.4. Toxicity: The solution shall have an Acute Oral Toxicity Value (LD50) of more than five ml/kg body weight (non-toxic) when tested in accordance with Paragraph 6.3.
5.5. Skin Irritancy: The solution shall not be a primary skin irritant or sensitizer when tested in accordance with Paragraph 6.4.
5.6. pH: The solution shall have a pH in the range of 4.0 -- 7.0.
5.7. Storage Stability: The solution shall show no loss of antimicrobial action after one (1) year of storage at temperatures in the range of 50 ° -- 86 °F.
6. TESTING: Testing shall be done by, or at the direction of, the Commission and/or the receiving State agency. Tests shall be performed on products from shipments to ordering agencies. In the event products tested fail to meet or exceed all conditions and requirements of this specification, the cost of the samples used and the cost of testing shall be borne by the supplier.
6.1. The products furnished under this specification shall be tested by the following methods or approved equally applicable procedures:
6.1.1. Titratable Iodine: Titrate with standard sodium thisfulfate solution by a conventional iodometric procedure.
6.1.2. Anti-microbial Effectiveness: Determine compliance with 21 CFR 333, issued by the Food and Drug Administration. Perform in-vitro testing by the use dilution method of AOAC.
6.1.3. Toxicity: Determine LD50 with white rats, by the method of 16 CFR 1500.3, issued by the Consumer Product Safety Commission.
6.1.4. Skin Irritancy: Determine compliance with 16 CFR 1500.3., by the skin patch test.
6.1.5. Certification: Upon request from the Commission, the vendor shall submit laboratory test results from the manufacturer with the bid.
7. SAMPLES: Unless otherwise specified in the Invitation for Bids, no prepurchase samples shall be required. Samples tested shall be obtained from products supplied on regular orders.
8. INSPECTION: Products furnished under this specification shall be inspected by, or at the direction of, the Commission and/or the ordering State agency either at the destination or place of manufacture.
9. WARRANTY: All solutions shall carry the manufacturer's standard warranty and shall be guaranteed against defects in materials and performance for a minimum of one (1) year. The warranty shall begin on the date of acceptance of the unit by the ordering agency. During this warranty period, the vendor shall replace defective components and/or units at no cost to the State of Texas.
10. PACKING and/or PACKAGING: Packaging for shipment shall be in accordance with the manufacturer's standard practice and in a manner readily accepted by common carriers engaged in interstate commerce. Within the shipping carton, units shall be packed in a manner designed to minimize damage during shipment due to rough or improper handling.
10.1. Containers: The product shall be packaged in the following container sizes, or as specified in the Invitation for Bids.
10.1.1. One (1) pint containers, twelve (12) per case.
10.1.2. One (1) quart containers, six (6) per case.
10.1.3. One (1) gallon containers, four (4) per case.
11. MARKING and/or LABELING:
11.1. Marking: Each shipping container shall be clearly marked with:
11.1.1. Name of contents.
11.1.2. Quantity contained in U.S. liquid measure.
11.1.3. Name and address of the manufacturer.
The container or shipping documents shall include:
11.1.4. Order number or contract number.
11.1.5. Name and address of ordering agency.
11.1.6. Agency requisition number.
11.2. Labeling: Each product container shall bear a securely affixed and durable label including the following information:
11.2.1. Name of the product including brand name, if any.
11.2.2. Net contents, in U.S. liquid measure.
11.2.3. Active ingredient contents, precautionary statements, and other data as required by the Food and Drug Administration.
11.2.4. Instructions for use.
11.2.5. Name and address of the manufacturer.
12. BID LITERATURE: All bids shall be accompanied by a description of the products being offered.
13. COMPLIANCE: In order for consideration to be given to the bid on an item under this specification, the bidder must comply with the following conditions.
13.1. Equipment Identification: The make, model number, name of the manufacturer, brand or trade name, etc., as applicable, of the item which the vendor proposes to furnish must be state as part of the bid.
13.2. Exceptions: Notwithstanding the above, any exception taken by the bidder to the requirements and conditions of this specification must be stated and described in detail as a part of the bid. If no exceptions or deviations are identified in this manner, the items must be furnished exactly as described herein.
13.3. Proof: The bidder shall bear the burden of proof of compliance with this specification.
13.4. Certification: When so specified in the Invitation for Bids, the bidder shall submit laboratory test results from the manufacturer with the bid.
14. PRODUCT INFORMATION: Non-irritating skin antiseptics are intended for use as a general anti-infective agent, and for use in pre- and post-surgical applications. The iodophor reduces the irritancy of the iodine. Note: For surgical site preparation, allow the area to dry to preclude pooling.
15. ORDERING DATA: When ordering products conforming to this specification, the requisitioning agency shall specify the following:
15.1. The number of this specification (435-04-01A).
15.2. Size (s) container desired (See Paragraph 10.1.).
15.3. Quantity of cases of each size required.
16. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by writing or calling:
Texas Procurement and Support Services
P. O. Box 13186
Austin, TX 78711-3047