Glossary

Putting sequenced fragments of DNA into their correct chromosomal positions.

A low level programming language, that corresponds closely to the instruction set of a given computer, allows symbolic naming of operations and addresses, and usually results in a one-to-one translation of program instructions (mnemonics) into machine instructions.

Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

(NIST) A logical expression specifying a program state that must exist or a set of conditions that program variables must satisfy at a particular point during program execution.

(NIST) Checking of user- embedded statements that assert relationships between elements of a program. An assertion is a logical expression that specifies a condition or relation among program variables. Tools that test the validity of assertions as the program is executing or tools that perform formal verification of assertions have this feature.

NBS) A dynamic analysis technique which inserts assertions about the relationship between program variables into the program code. The truth of the assertions is determined as the program executes.

Investigation of processes, systems, or platforms by a subject-matter expert or by IT Quality

Investigation of processes, systems, or platforms by a subject-matter expert or by IT Quality and Compliance. An assessment does not need to be independent in contrast to audit.

The formation of cellular material utilizing small food molecules and energy.

A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with regulations governing the protection of human subjects in research. Assurance is the word used in the Federal Policy.

A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.

A disease marked by recurrent attacks of distress in breathing (dyspnea), due to some temporary change in the bronchial tubes or to a reflex spasm of the diaphragm. In many or most cases an allergic phenomenon due to sensitization to certain emanations from plants or animals or to food products in respect to which the victim has hypersensitiveness.

Association of State and Territorial Health Officials

American Society for Testing and Materials

A not-for-profit organization that provides a forum for the development and publication of voluntary consensus standards for materials, products, systems, and services. ASTM develops standard test methods, specifications, practices, guides, classifications, and terminology in 130 areas covering subjects such as metals, paints, plastic, textiles, petroleum, construction, energy, the environment, consumer products, medical services and devices, computerized systems, electronics, and many others. www.astm.org

This specification covers grades of nominal wall thickness, seamless and welded austenitic stainless steel intended for general corrosion resisting and low or high temperature service. www.astm.org

This specification covers grades of seamless and welded austenitic stainless steel sanitary tubing having special surface finishes and intended for use in the dairy, pharmaceutical, and food industries. Tolerances are much tighter than those in ASTM A269 and ASTM A312, allowing a closer alignment of tube to tube, and tube to fittings, which is necessary for compatibility with automatic orbital welding. This specification covers tubes in sizes up to and including 6”. www.astm.org

This specification covers stainless steel pipe intended for high temperature and general corrosive service. In contrast to sanitary tubing, industrial piping and components are not compatible for sterile service due to their basic design and manufacturing techniques. However, due to the size limitations of sanitary tubing, industrial piping NPS (Nominal Pipe size) must be used in large-scale biotechnology or pharmaceutical facilities. When industrial piping and components are selected, high quality standards must be met, particularly where their internal finishes and fit-up is concerned, to assure that piping systems have a minimum of places for product entrapment, and that the systems are sanitizable and sterilizable. www.astm.org

This practice covers recommendations for cleaning, descaling, and passivating new stainless steel parts, assemblies, equipment, and installed systems. These recommendations are presented as procedures for guidance when it is recognized that for a particular service it is desired to remove surface contaminants that may impair the normal corrosion resistance, or result in the later contamination of the particular stainless steel grade, or cause product contamination.

This specification covers several different types of chemical passivation treatments for stainless steel parts. It includes recommendations and precautions for descaling, cleaning, and passivation of stainless steel parts. It includes several alternative tests, with acceptance criteria, for confirmation of effectiveness of such treatments for stainless steel parts.

This specification covers the passivation of stainless steel alloys in the 200, 300, and 400 series, and the precipitation-hardened alloys, using electropolishing procedures.

This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety. This guide is applicable throughout the life–cycle of both new and existing manufacturing systems.

Occurring without a regular time relationship, i.e., timing independent.

A timing independent method of electrical transfer of data in which the sending and receiving units are synchronized on each character, or small block of characters, usually by the use of start and stop signals.