Glossary

The action of confining within a defined space a microbiological agent or other entity that is being cultured, stored, manipulated, transported, or destroyed in order to prevent or limit its contact with people and/or the environment. Methods to achieve containment include physical and biological barriers and inactivation using physical or chemical means.1.Primary Containment. Addresses the protection of personnel and the immediate laboratory environment from exposure to infectious agents. It involves the use of closed containers or safety biological cabinets along with secure operating procedures.2.Secondary Containment. A system of containment that prevents the escape of infectious agents into the environment external to the laboratory. It involves the use of rooms with specially designed air handling, the existence of airlocks and/or sterilizers for the exit of materials and secure operating procedures. In many cases it may add to the effectiveness of primary containment.The main three elements of containment include laboratory practice and technique (most important element), safety equipment (primary barriers), and facility design (secondary barriers).

The physical means to prevent the entry of hazardous material into the workplace - to protect the worker (and work environment) from materials that are potentially hazardous (as a byproduct of this the product may also be protected).1.Primary Containment. The protection of workers and the product from exposure to potentially hazardous agents, via the use of closed systems and physical segregation.2.Secondary Containment. The control of contaminants, through system and equipment design, to prevent the release of potentially hazardous agents to the outside environment, via spatial layouts and adjacencies, flow patterns and directional airflow and pressure boundaries.

State achieved by separative devices with high degree of separation between operator and operation.

Physical means to prevent the entry of hazardous material into the workplace to protect the worker and the work environment from materials that are highly active biologically or pharmacologically, toxic, or biohazardous, usually in addition to protecting the product from contamination.1.Primary Containment. The protection of workers and the product from exposure to potentially hazardous agents, via the use of closed systems and physical segregation.2.Secondary Containment. The control of contaminants, through system and equipment design, to prevent the release of potentially hazardous agents to the outside environment, via spatial layouts and adjacencies, flow patterns and directional airflow and pressure boundaries.

State achieved by enclosures with separation between manufacturing environment and manufacturing operation. The action of confining a biological agent or other identity within a defined space.

A type of closed isolator that is sealed or is supplied with air through a particle retentive filtration system (HEPA minimum) and is able to be reproducibly cleaned after use. When closed it uses only interfaces or Rapid Transfer Ports (RTPs) for material transfer. When open it allows the ingress of materials through a defined opening that has been designed and validated to preclude the release of contamination to the surrounding environment.

Engineering controls primarily used to reduce the risk of dust emissions by separating the process from the immediate manufacturing environment or by using airflow to capture the emissions.

A foreign agent or material that is external to processing, such as airborne particulates or adventitious organisms.

Any particulate, molecular, non-particulate and biological entity that can adversely affect the product or process. ISO 14644-4.

Any foreign component present in another substance. For example, anything in water that is not H2O is a contaminant.

Any foreign component present in another substance. For example, anything in water that is not H2O is a contaminant.

Common name for a group of compounds with a specific and similar deleterious effect when deposited on the surface of interest.

(ICH Q6B) Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product.

(ICH Q7) The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

The undesired introduction of impurities of a physical, chemical or microbiological nature, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

Risk assessment to systematically review the process, unit operation by unit operation, to identify potential risks arising from the physical contamination of the API both internal and external to the equipment, and enabling Levels of Protection to be defined.

Patterns of codon usage, which are unique to each species, that allow protein-coding sequences to be distinguished from surrounding non-coding sequences.

Group of cloned (copied) pieces of DNA representing overlapping regions of a particular chromosome (whether natural or artificial, as in BACs).

The alignment of sequence data from large, adjacent regions of the genome to produce a continuous nucleotide sequence across a chromosomal region.

Monies predefined to support specific unforeseen project changes.

(ICH Q10) Recurring activity to increase the ability to fulfill requirements. (ISO 9000:2005)

(FDA – 2011) Assuring that during routine production the process remains in a state of control.

Updating that occurs constantly. ISO 14644-2.

(ICH Q5D) A cell line having an infinite capacity for growth. Often referred to as “immortal” and previously referred to as “established”.