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435/16-02b

Texas Specification No. 435-16-02B

Effective Date: January 15, 1992

Reformatted Date: June 28, 1996

SPECIFICATION

for

SURGICAL SCRUB SKIN CLEANSER, HEXACHLOROPHENE TYPE

1. SCOPE: This specification establishes the minimum requirements for an anti-infective, antibacterial, hexachlorophene type surgical scrub sudsing skin cleanser in emulsion form for topical administration.

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 skin cleanser shall be classified by a hexachlorophene percentage of three percent (3%).

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 surgical scrub shall cleanse the skin thoroughly and shall reduce the gram positive bacterial flora of the skin when used in hard, soft, hot or cold water.

5.2. Chemical Composition: the scrub shall be a stable colloidal dispersion containing 3.0% hexachlorophene by weight in an emulsion of emollients and detergents. The preparation shall not contain soap in any form.

5.3. FDA Approval: The surgical scrub shall be approved by the Food and Drug Administration as required by 21 CFR 250.250.

5.4. Anti-microbial Effectiveness: The scrub 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,

Staphylococcus aureus ATCC # 6538

Staphylococcus aureus ATCC # 25923

Streptococcus pyogenes ATCC # 8668

5.4. Toxicity: The scrub shall have an Acute Oral Toxicity Value (LD50) of more than sixty-six (66) ml/kg of body weight (non-toxic) when tested in accordance with Paragraph 6.3.

5.5. Skin Irritancy: The scrub may be irritating to the skin when tested in accordance with Paragraph 6.4. and should be used only as long as necessary for infection control. See Paragraph 14.

5.6. pH: the scrub shall have a pH in the range of 5.0 -- 6.0.

5.7. Storage Stability: The scrub shall show no loss of antimicrobial action after one (1) year 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. 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.

6.1.2. Toxicity: Determine LD50 with white rats, by the method of 16 CFR 1500.3, issued by the Consumer Product Safety Commission.

6.1.3. Skin Irritancy: Determine compliance with 16 CFR 1500.3., by the skin patch test.

6.1.4. 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, twenty-four (24) per case.

10.1.2. One (1) gallon containers, four (4) per case.

10.2. Dispensers: When so specified in the Invitation for Bids, refillable dispensers, made from metals and plastics compatible with hexachlorophene, shall be supplied.

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:

14.1. Scrub: The manufacturer's recommendations on use should be followed closely. For preoperative use, wet hands and forearms and lather with two (2) separate three (3) minute scrubs with a brush, using at least five (5) ml of the product during each scrub. Remove excessive amounts of foreign matter, if present, prior to the scrub. Rinse thoroughly and dry.

14.2. Bacterial Action: Hexachlorophene surgical scrubs provide bacteriostatic action against gram positive organisms only. Cumulative antibacterial action develops with repeated use. Alcohol or soaps with alcohol remove the antibacterial residue.

14.3. Toxicity: Toxic amounts of hexachlorophene can be absorbed through human skin, especially damaged or burned skin or the skin of infants. This bacteriostatic skin cleanser should be used only as long as necessary for infection control. Adverse reactions include dermatitis and photosensitivity.

15. ORDERING DATA: When ordering products conforming to this specification, the requisitioning agency shall specify the following:

15.1. The number of this specification (435-16-02B).

15.2. Size (s) container desired (See Paragraph 10.1.).

15.3. Dispensers, if required (See Paragraph 10.2).

15.4. Quantity of cases of each size required.

16. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by writing or calling:

Bid Services
Texas Procurement and Support Services
P. O. Box 13186
Austin, TX 78711-3047
(512) 463-3416

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