ISO 11737 – Sterilization of Health Care Products – Microbiological Methods
A sterile health care product is one that is free of viable microorganisms. International Standards that specify requirements for the validation and routine control of sterilization processes require, when it is necessary to supply a sterile health care product, that adventitious microbiological contamination of a health care product prior to sterilization be minimized. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.
For additional information:
ISO 11737-1:2018(en), Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices.
For additional information:
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
ASTM D6978-05 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.
For additional information:
PPE-Info - Standard Details (cdc.gov)
Certificate of Irradiation
Certificates of Irradiation (COI) document the minimum and maximum dosage of irradiation that a product received, and are available for all sterile products. Sterilization validation documentation confirms that the doses have been verified, the loading patterns are sufficient, and that the process is audited on a regular basis.
PPE Chemical Permeation, Degradation & Penetration
Ideally, the chosen material(s) must resist permeation, degradation, and penetration by the respective chemicals.
Permeation is the process by which a chemical dissolves in or moves through a material on a molecular basis. In most cases, there will be no visible evidence of chemicals permeating a material.
Permeation breakthrough time is the most common result used to assess material chemical compatibility. The rate of permeation is a function of several factors such as chemical concentration, material thickness, humidity, temperature, and pressure. Most material testing is done with 100% chemical over an extended exposure period. The time it takes chemical to permeate through the material is the breakthrough time. An acceptable material is one where the breakthrough time exceeds the expected period of PPE use. However, temperature and pressure effects may enhance permeation and reduce the magnitude of this safety factor. For example, small increases in ambient temperature can significantly reduce breakthrough time and the protective barrier properties of a protective PPE material.
Degradation involves physical changes in a material as the result of a chemical exposure, use, or ambient conditions (e.g. sunlight). The most common observations of material degradation are discoloration, swelling, loss of physical strength, or deterioration.
Penetration is the movement of chemicals through imperfections in PPE material including pinholes and tears.
It is important to note that no material protects against all chemicals and combinations of chemicals, and that no currently available material is an effective barrier to any prolonged chemical exposure.
For additional information:
OSHA Technical Manual (OTM) - Section VIII: Chapter 1 | Occupational Safety and Health Administration
Pyrogen and Endotoxins Testing
The USP now recognizes two tests - The Pyrogen Test conducted with rabbits and the Bacterial Endotoxins Test, also termed the Limulus Amebocyte Lysate (LAL) Test. Additionally, the agency has approved the use of the Bacterial Endotoxins Test for many drug and device products.
For additional information:
Bacterial Endotoxins/Pyrogens | FDA
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers | FDA
USP 800
USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
For additional information:
USP 800 | USP
USP_FAQs_on_GC_800.pdf
800-know-your-exposure-to-hazardous-drugs.pdf (usp.org)
Food Contact Compliance – 21 CFR
The formulations of the following Kimberly-Clark™ Scientific Gloves have been tested and the ingredients have been found to comply with the Federal Food, Drug and Cosmetic Act requirements for food contact materials as stated in the following regulations:
• 21 CFR 177.2600, “Rubber articles intended for repeated use.”
• 21 CFR 178, “Indirect Food Additives: Adjuvants, Production Aids and Sanitizers.”
• 21 CFR 178.3297, “Colorants for Polymers.”
• 21 CFR 177.2600(e), An extraction test was performed to confirm that the product complies with the regulation.
For additional information:
eCFR :: 21 CFR Chapter I Subchapter B -- Food for Human Consumption
Certificate of Analysis
The CGMP regulations require either testing or use of a certificate of analysis (COA) plus an identity analysis (§ 211.84) for the release of materials for manufacturing. In the preamble to the CGMP regulations, these requirements were explicitly interpreted. The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the supplier’s COA.
For additional information:
Guidance for Industry (fda.gov)
Sterilization for Medical Devices
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).
For additional information:
Sterilization for Medical Devices | FDA
Sterilization | Disinfection & Sterilization Guidelines | Guidelines Library | Infection Control | CDC
Gamma Irradiation Processing:
Gamma Irradiation Sterilization Process & Services | STERIS AST (steris-ast.com)