Glossary

European Union Emissions Trading System

The largest representative body of the European Medical Technology and Devices Industry.

European Federation for Pharmaceutical Sciences

The study of improving a species by artificial selection; usually refers to the selective breeding of humans.

An organism that carries its genetic material physically constrained within a nuclear membrane separate from the cytoplasm. All animal and plant cells except bacteria, viruses, and bluegreen algae are eukaryotic. Eukaryotes are five to ten times larger than prokaryotes in diameter.

Experimental User Permit

A consortium of equipment manufacturers, food industries, research institutes and public health authorities, founded in 1989 with the aim to promote hygiene during the processing and packing of food products. European legislation requires that handling, preparation, processing, packaging, etc. of food is done hygienically (the Food Hygiene Directive Regulation (EC) 852-853-854/2004), with hygienic machinery (the Machinery Directive (98/37/EC)), and in hygienic premises (Regulation (EC) No. 1935/2004 of the European Parliament on materials and articles intended to come into contact with food). The objectives of EHDG are: 1. To provide guidance on the hygienic engineering aspects of manufacturing safe and wholesome food.2. To provide guideline documents on essential hygienic design standards and practices based on science and technology, and to periodically review them. These provide guidance to equipment manufacturers and users on compliance with national and international legislation.3.To develop test methods that can be used by third parties for hygienic design assessment to aid compliance with relevant legislation.4.To ensure that the use of the EHEDG name and logo is properly controlled.5.To identify areas where knowledge of hygienic design is insufficient and to encourage research and development in such areas.6.To provide a balanced forum for European food processing equipment manufacturers, users and regulators to discuss issues on hygienic design to support food safety and wholesomeness.

The Hygienic Equipment Design Group Guidelines describe the criteria for the hygienic design of equipment intended for the processing of foods. Their fundamental objective is the prevention of the microbial contamination of food products. They are intended to apprise qualified engineers who are designing equipment for food processing with the additional demands of hygienic engineering in order to ensure the microbiological safety of the end product. Upgrading an existing design to meet hygiene requirements can be prohibitively expensive and may be unsuccessful and so these are most effectively incorporated into the initial design stage. The long term benefits of doing so are not only product safety but also the potential to increase life expectancy of equipment, reduce maintenance and consequently lower operating costs. These documents were first published in 1993 with the intention to describe in more detail the hygienic requirements of the Machinery Directive (98/37/EC ref.1). Parts of them were subsequently incorporated in the standards EN1672-2 and EN ISO 14159.The US-based organizations NSF (National Sanitation Foundation) and 3-A SSI (3-A Sanitary Standards, Inc.) have agreed to co-operate in the development of EHEDG Guidelines and in turn, EHEDG co-operates in the development of 3-A and NSF standards.EHEDG may authorize the use of the EHEDG Certification logo for equipment complying with Document 8 - Hygienic Equipment Design Criteria. Certification may involve cleanability testing of equipment according to the methodology described in Document 2 - A Method for Assessing the In-Place Cleanability of Food Processing Equipment. EHEDG has authorized several organizations to certify the use of EHEDG compliance logo. Testing and certification are independent activities and may be done by different organizations.The current titles of the EHEDG Guidelines are:1. Microbiologically safe continuous pasteurization of liquid foods.2. A method for assessing the in-place cleanability of food processing equipment, SG Test Methods.3. Microbiologically safe aseptic packing of food products.4.A method for the assessment of in-line pasteurization of food processing equipment, SG Test Methods.5.A method for the assessment of in-line sterilisability of food processing equipment, SG Test Methods.6.The microbiologically safe continuous flow thermal sterilization of liquid foods.7.A method for the assessment of bacteria tightness of food processing equipment, SG Test Methods.8.Hygienic equipment design criteria.9.Welding stainless steel to meet hygienic requirements.10.Hygienic design of closed equipment for the processing of liquid food.11.Hygienic packing of food products.12.The continuous or semi-continuous flow thermal treatment of particulate foods.13.Hygienic design of equipment for open processing.14.Hygienic requirements on valves for food processing.15.A method for the assessment of in-place cleanability of moderately-sized food processing equipment, SG Test Methods.16.Hygienic pipe couplings.17.Hygienic design of pumps, homogenizers and dampening devices SG Pumps.18.Passivation of stainless steel.19.A method for assessing the bacterial retention ability of hydrophobic membrane filters, SG Test Methods.20.Hygienic design and safe use of double-seat mixproof valves, SG Valves.21.Challenge tests for the evaluation of the hygienic characteristics of packing machines for liquid and semi-liquid products, SG Packing Machines.22.General hygienic design criteria for the safe processing of dry particulate materials, SG Dry Materials Handling.23.Production and use of food-grade lubricants, SG Lubricants.24.Prevention and control of Legionella spp. (including legionnaires disease) in food factories, SG Process Water.25.Design of mechanical seals for hygienic and aseptic applications, SG Mechanical Seals.26.Hygienic engineering of plants for the processing of dry particulate materials, SG Dry Materials Handling.27.Safe storage and distribution of water in factories.28.Safe and hygienic water treatment in food factories.29.Hygienic design of packing systems for solid foodstuffs.30.Guidelines on our handling in the food industry.31.Hygienic engineering of fluid bed and spray dryer plants.32.Materials of construction for equipment in contact with food.33.Hygienic engineering of discharging systems for dry particulate material.34.Integration of hygienic and aseptic systems.35.Hygienic welding of stainless steel tubing in the food processing industry (27 pages), ISBN 978-0-907503-26-8.

Of, pertaining to, or formed at the lowest possible temperature of solidification for any mixture of specified constituents. A common term used to describe metal alloys.

Ethylene Vinyl Acetate

A critical summary and interpretation of the data, with conclusions, prepared by or on behalf of the drug regulatory authority.

The process by which a liquid is changed into a vapor and mixed into the surrounding air.

The rate at which a liquid is changed to a vapor under standard conditions, usually compared to the rate of another substance that evaporates very quickly.

Apparatus used in distillation to heat a liquid and create a phase change from the liquid to the vapor state. A steam boiler is an evaporator.

A table which lists events and the corresponding specified effect(s) of or reaction(s) to each event.

An approach to practicing medicine that involves consideration of results of clinical trials that are relevant to the disease or condition being treated when making decisions about how to treat patients.

Ethylene Vynil Alcohol copolymer

Expert Working Group (ICH)

(IEEE) An event that causes suspension of normal program execution. Types include addressing exception, data exception, operation exception, overflow exception, protection exception, underflow exception.

A special type of event table.

Those functions that deal with plant or process contingencies and other events which occur outside the normal or desired behavior of batch control.

Excessive heat means any temperature above 40ºC (104ºF).

Weld penetration that exceeds the acceptance limit for inside diameter convexity.

(ICH Q6B) An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used.