Definitions Related to Contamination and cross-contamination

Contamination and cross-contamination in pharmaceuticals can greatly impact drug safety, effectiveness, and general public health. Here are some important definitions related to contamination and cross-contamination.

Definitions related to Contamination and cross-contamination:

Alert Limit: An established value that, when exceeded, provides an early warning of potential drift from the normal operating conditions and validated state. This type of warning does require an appropriate documented investigation. (e.g. trend analysis) and may require Corrective actions depending on the results of the investigation.

Action Limit: An established value that, when exceeded, indicates a process is outside of its normal operating conditions. Responding to such an excursion requires a documented investigation, product impact assessment, and corrective actions based on the investigation results.

Aseptic Filling: Part of aseptic processing in which a pre-sterilized or aseptically manufactured product is filled and sealed into sterile containers in a critical area, RABS or Isolator.

Aseptic Processing: Handling of product, packaging materials, and processing equipment in a controlled environment where the air supply, materials, equipment, and personnel are controlled to maintain product sterility.

Bioburden: The type and number of microorganisms per unit of material.

Clean area: An area with defined particle and microbiological cleanliness standards usually containing several joined cleanro0ms.

Cleaning: A process for removing contaminations e.g. product residues or disinfectant residues.

Cleanroom: A room designed, maintained, and controlled to prevent particle and microbiological contamination of a drug or medical device. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.

Cleanroom classification: A method of assessing the level of air cleanliness against a specification for clean air equipment by measuring the total particle concentration.

Closed System: A system in which the sterile product is not exposed to the surrounding environment.

Contamination: The undesired introduction of impurites of a physical, chemical or microbiological nature or any foreign matter, into or onto a material or product during production, sampling, packaging or repackaging, storage, or transport. Contamination could be intrinsic (from inherent process) or extrinsic (externally sourced)

Contamination Control Strategy: A planned set of controls for microorganisms, endotoxin/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to the active substance, excipient, and drug product material and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.

Cross Contamination: An Accidental inclusion of a product of another batch or unknown foreign material into a finished batch that was not intended or not mentioned on the label.

Control Measure: A step taken to minimize the risk of contamination.

Critical Area/Critical Zone: An area/zone designed to maintain the sterility of materials where sterilized products, containers, closures, and equipment may be exposed to the manufacturing environment.

Documentation: The overall process of removal or reduction of any contaminants (chemical residue or microorganism) from an area, processing equipment, or person. The method documentation used (e.g. cleaning, disinfection, sterilization) shall be chosen and validated to achieve a level of cleanliness appropriate to the intended use of the item decontaminated.

Disinfection: The process by which the reduction of the number of microorganisms is achieved by the irreversible action of a product on its structure or metabolism, to a level deemed to be appropriate for a defined purpose.

Grade A air supply: Air that is passed through a filter qualified as capable of producing grade A total particle quality air, but where there is no requirement to perform continuous total particle monitoring or meet grade A viable monitoring limits.

Isolator: An enclosure capable of being subject to reproducible interior bio-decontamination, with an internal work zone meeting grade A conditions that provide uncompromised, continuous isolation of its interior from the exterior environment (e,g. surrounding cleanroom air and personnel).

Closed Isolator: Systems exclude external contamination from the isolator’s interior by transfer of material via aseptic connection to auxiliary equipment, rather than using openings to the surrounding environment. The closed system remains sealed throughout the operation.

Open Isolator: Systems are designed to allow for the continuous or semicontinuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g. using continuous overpressure) to exclude the entry of external contamination into the isolator.

Restricted Access Barrier System (RABS): A system that provides an enclosed but not fully sealed, environment meeting defined air quality conditions (for aseptic processing grade A), and using rigid-wall enclosure and integrated gloves to separate its interior from the surrounding cleanroom environment The inner surfaces of the RAES are disinfected decantaminated with a sporicidal agent. Operators use gloves half suits, ATPs, and RTP’s integrated transfer parts to perform manipulations or convey materials to the Interior of the RABS. Depending on the design, doors are rarely opened, and only under strictly pre-defined conditions

Sanitization: Process of reducing the number of all forms of microbial contamination including fungi, viruses, and bacteria.

Sterilization: A process used to render a system free of viable microorganisms with a specified probability.

These are the definitions related to contamination and cross-contamination in the pharmaceutical industry.

definitions related to contamination and cross-contamination

Definitions related to contamination and cross-contamination

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