Biomaterial Database

HACCP and its implications for sterile medical device packaging. 2001

R Pilchik

Mocon, Minneapolis, Minnesota, USA. ronp@netreach.net

Strength and integrity are the two attributes that must be monitored at the critical point. Strength can effectively be monitored by operating the sealing equipment within the validated control limits. Integrity is another matter entirely. Integrity failures are often random occurrences that must be visible to the trained operator. Yet, this is not true in every instance. Use of precise testing equipment, which exceeds the capabilities of visual testing, is a more effective way to manage the critical control point. New technology to more effectively test the attributes of seal and package integrity at the critical control point is currently under development. Data on its capabilities will shortly be available.

UI	MeSH Term	Description	Entries
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D004866	Equipment Contamination	The presence of an infectious agent on instruments, prostheses, or other inanimate articles.	Contamination, Equipment,Contaminations, Equipment,Equipment Contaminations
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.
D017751	Safety Management	The development of systems to prevent accidents, injuries, and other adverse occurrences in an institutional setting. The concept includes prevention or reduction of adverse events or incidents involving employees, patients, or facilities. Examples include plans to reduce injuries from falls or plans for fire safety to promote a safe institutional environment.	Hazard Management,Hazard Control,Hazard Surveillance Program,Safety Culture,Control, Hazard,Culture, Safety,Cultures, Safety,Hazard Controls,Hazard Surveillance Programs,Management, Hazard,Management, Safety,Program, Hazard Surveillance,Programs, Hazard Surveillance,Safety Cultures,Surveillance Program, Hazard,Surveillance Programs, Hazard
D019064	Product Packaging	Form in which product is processed or wrapped and labeled. PRODUCT LABELING is also available.	Packaging, Product,Product Containers,Packaging,Container, Product,Containers, Product,Packagings,Packagings, Product,Product Container,Product Packagings
D019544	Equipment Failure Analysis	The evaluation of incidents involving the loss of function of a device. These evaluations are used for a variety of purposes such as to determine the failure rates, the causes of failures, costs of failures, and the reliability and maintainability of devices.	Materials Failure Analysis,Prosthesis Failure Analysis,Analysis, Equipment Failure,Analysis, Materials Failure,Analysis, Prosthesis Failure,Analyses, Equipment Failure,Analyses, Materials Failure,Analyses, Prosthesis Failure,Equipment Failure Analyses,Failure Analyses, Equipment,Failure Analyses, Materials,Failure Analyses, Prosthesis,Failure Analysis, Equipment,Failure Analysis, Materials,Failure Analysis, Prosthesis,Materials Failure Analyses,Prosthesis Failure Analyses