Glossary

The ability to withstand the rigors of the environment without degrading or requiring repair.

Defense University Research Initiative Program

Measurement of hardness related to the resistance to penetration of an indenter point into a material as typically determined by ASTM D 2240 (Standard Test Method for Rubber Property – Durometer Hardness).

The measure of the ability of a filter to remove synthetic dust when tested as described in ASHRAE Standard 52.2-2008, Method of Testing General Ventilation Air Cleaning Devices for Removal Efficiency by Particle Size.

“Dustiness” is a commonly used term to define the propensity of the material to form stable dust aerosols and is usually considered to be a function of:•particle size•particle shape•electrostatic charge•moisture content•material densityAs a parameter it is not easily defined or quantified, though some research has previously defined a ”dustiness index” to allow a degree of comparative quantification. Within the scope of this guidance document (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment), it is recommended that surrogates of qualitatively similar dustiness to the drug product are used wherever possible.

Deterioration of the finish at the surface so it is easily loosened from the surface by light physical contact (such as wiping one’s hand across the surface), mechanically induced air movements or naturally occurring air movements.

Digital Versatile Disk

Direct Expansion

Analysis that is performed by executing the program code.

Environmental conditions of a manufacturing room occupied by the normal number of workers appropriately garbed and with production equipment in operation. However, dynamic conditions for some dusty operations, such as aseptic powder filling, may be measured in the absence of product.

Live data/records that reside within an on-line data repository such as a database. The opposite to static data/records.

Seal with a component that is in motion relative to a second surface.