Glossary of Terms

Accelerated Hydrogen Peroxide® (AHP®) is a formulation of Hydrogen Peroxide, surfactants and other inert ingredients which results in a stabilized and a dramatically more effective disinfectant and cleaner.

The rate of air movement measured in distance traveled relative to time elapsed. Air velocity is commonly measured in meters per second (m/s) or feet per minute (ft/min).

Stream of air as it passes over the surface of a moving object or within a wind tunnel where air may move over the surface of a stationary object.

The consistency of which a stream of air passes over the surface of an object. Measured in volume occupied relative to time elapsed. Common airflow uniformity is measured in cubic meters per second (m³/s), liters per second (L/s), or cubic feet per minute (ft³/min).

Active Pharmaceutical Ingredient

A cleanroom that is complete, functional and ready for operation, but without the equipment and personnel inside.

Testing a cleanroom as-built, reflects the quality of the supply air.

A cleanroom that is complete, functional and ready for operation, with the equipment inside, but without the personnel.
Testing a cleanroom at-rest allows for smoke testing over critical equiment surfaces to check positioning.

Biological safety levels are ranked from one to four and are selected based on the agents or organisms on which the research or work is being conducted.
Each level up builds on the previous level, adding constraints and barriers.
The Centers for Disease Control and Prevention (CDC) sets BSL lab levels as a way of exhibiting specific controls for the containment of microbes and biological agents.

Biotechnology companies are derived from living organisms.
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Biosafety cabinet —also called a biological safety cabinet or microbiological safety cabinet.
The Centers for Disease Control and Prevention (CDC) sets BSL lab levels as a way of exhibiting specific controls for the containment of microbes and biological agents.
Biosafety Levels.
Biosafety Levels (BSL) prescribe procedures and levels of containment for the particular microorganism or material.

Compliance Audit Program
During a CAP inspection, various aspects of the laboratory's operations and management are evaluated, including procedure manuals, completeness of records, types and methods of quality control and factors that indicate that the lab is meeting high-quality standards.

Contract Development Manufacturing Operations

A colony-forming unit (CFU, cfu, Cfu) is a unit used in microbiology to estimate the number of viable bacteria or fungal cells in a sample. Viable is defined as the ability to multiply via binary fission under the controlled conditions. Counting with colony-forming units requires culturing the microbes and counts only viable cells, in contrast with microscopic examination which counts all cells, living or dead. The visual appearance of a colony in a cell culture requires significant growth, and when counting colonies it is uncertain if the colony arose from one cell or a group of cells. Expressing results as colony-forming units reflects this uncertainty.

A designated space that is closely controlled for compliance to limitations that have been outlined for operating procedures, air cleanliness, air pressure, temperature, relative humidity, and air flow patterns. A number of devices and procedures are often used in a cleanroom to monitor the viability of airborne particles.

Non-shedding apparel that is designed specifically to serve as a barrier between cleanroom environments and possible contaminants released by cleanroom workers. Cleanroom garments may include footwear, shoe covers, coveralls, gowns, smocks, gloves, face masks, and head coverings.

Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian countries. Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations. These Grades can be related to the ISO Classes.

Classification system used to determine the acceptable concentration of particles in an identified volume of air given specific particle size parameters. Classification levels are determined by the federal government. The primary authority in the US and Canada is the ISO classification system ISO 14644-1. This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8.

A space or system of spaces in which there are tightly controlled limits that govern air flow, air pressure, air filtration, temperature, relative humidity, viability of airborne particles, access, and operating procedures.

Cleanroom facility that is prepared for operation in terms of construction and systems but without staff present or manufacturing equipment in place.

Cleanroom facility that is fully equipped for operation with the exception of staff on site.

Cleanroom facility that is equipped and staffed for full operations, with all staff, equipment, and supplies present.

Cleanroom and Controlled Environment Consulting.

In the pharmaceutical industry, one term is becoming increasingly important: containment. It describes the process of containing a substance within a defined space, a method that is suitable for protecting operators and the environment in case of high toxicity and product reactivity. At the same time, containment prevents dust, gases or vapours from being released into the environment and contaminating the product.

A process that includes a level of sterilization with a 6-log or higher kill

What’s a controlled environment?

A controlled environment, or critical environment, is an area that must have certain parameters controlled, specifically, pressure, temperature, and segregation. Many laboratories are considered controlled environments, as they have controlled temperature and pressure and are separated from other operations, such as manufacturing or shipping. Unlike cleanrooms, controlled environments do not necessarily have to meet certain standards for particle contamination.

What’s a cleanroom?

A cleanroom is a type of controlled environment, but one with much more stringent requirements. Cleanrooms require temperature and pressure control, as well as separation from the outside environment and other operations, but these things must be controlled to specific standards. Cleanrooms are classified by the maximum acceptable numbers of particles (by size) in the air per cubic meter, and must be regularly tested to ensure compliance to that standard (see more about cleanroom classifications here). Compared with other controlled environments, cleanrooms may require more energy, air, and advanced technology to maintain the cleanroom conditions.

Read more: https://angstromtechnology.com/difference-controlled-environment-cleanroom/

A process that does not include decontamination or sterilization and achieves a 4/5-log kill

Environmental monitoring (EM) is a tool utilized by the pharmaceutical industry to measure and monitor microbial bioburden levels in a manufacturing facility. Periodic sampling of the air and surfaces within controlled environments allows the microbiologist to determine the approximate number and types of microorganisms present in a given area over a defined period of time. This data is analyzed through a process known as trending. Trending is performed in order to detect fluctuations in microbial levels, and allow firms to ensure that these levels remain within acceptable parameters. “Traditional” methods of trending EM data often include the use of excursion rates. “Excursion rate”, for the purpose of this article, is defined as the percentage of the total number of collected EM samples with counts exceeding either the alert or action level.

The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other's food safety systems as comparable to each other.

Filtering Facepiece RespiratorsThere are seven classes of filters for NIOSH-approved filtering facepiece respirators available at this time

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

Good Manufacturing Practice -GMP is also sometimes referred to as "cGMP". The "c" stands for "current"- is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Read more: Good manufacturing practices guide for drug products (GUI-0001)

Health care-associated infections (HAIs) are infections people get while they're receiving health care for another condition. HAIs can happen in any health care facility, including hospitals, ambulatory surgical centers, end-stage renal disease facilities, and long-term care facilities.

High-efficiency particulate air -also known as high-efficiency particulate absorbing and high-efficiency particulate arrestance, is an efficiency standard of air filter.

What is HOCL?
HOCl is a natural part of our internal defense system, produced by white blood cells.

When produced outside the body, HOCl is an electrolyzed, antimicrobial, biocide solution that inactivates pathogens such as bacteria, viruses, spores, and fungi.

Ionized Hydrogen Peroxide

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7.

Cleanroom air cleanliness classifications that provide standards for the identification, control, and monitoring of various airborne particles and contaminants.

Air stream that flows through a HEPA filter and moves with uniform velocity within a confined space. Alternately referred to as “unidirectional flow”, laminar air flow generally moves along parallel flow lines.

Unit of measurement for minuscule length equal to one-millionth of a meter or 0.00003937 inch. Expressed as µm and alternately referred to as a micrometer.

A test that samples a fixed volume of air and captures, filters and counts particles by their size. This is performed when the cleanroom is “at rest” or “in operation”. For pharmaceutical operations, both viable (alive) and non-viable (not alive) particle counts are performed. This is performed as part of the certification of a cleanroom and during regular environmental monitoring.

Pharmaceutical companies generally have a chemical basis.
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Personal Protective Equipment

Restricted-access barrier system -The RABS provides a physical barrier between workers and production areas

A series of tests that are performed to show that a cleanroom is operating at to its required class or grade.

Process that includes a level of clean with a 3-log kill

Phase One: Pre-Shutdown Activities (Planning and Scheduling) Phase Two: Declassification and Handover Phase Three: Day-To-Day Management and Handover Phase Four: Reclassification and Handover Phase Five: Post-Shutdown Activities and Completion of the Shutdown Report

Standard Operating Procedures

A decontamination process that kills, deactivates, or eliminates all biological agents

USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, delineates the standards for compounding sterile preparations in all pharmacy settings.

Vaporized hydrogen peroxide -also known as hydrogen peroxide vapor, HPV

Centers for Disease Control and Prevention.
CDC works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same.

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities

The Centers for Disease Control and Prevention (CDC) sets BSL lab levels as a way of exhibiting specific controls for the containment of microbes and biological agents.
Biosafety Levels
Biosafety Levels (BSL) prescribe procedures and levels of containment for the particular microorganism or material.

International Air Transport Association Serving the airline industry. We help airlines to operate safely, securely, efficiently, and economically under clearly defined rules. Professional support is provided to all industry stakeholders with a wide range of products and expert services.
IATA

As the lowest of the four, biosafety level 1 applies to laboratory settings in which personnel work with low-risk microbes that pose little to no threat of infection in healthy adults.

Examples of typical BSL-1 biological material:
Bacteria: Agrobacterium tumefaciens, Escherichia coli K-12, Pseudomonas fluorescens, Bacillus subtilis
Viruses: canine adenovirus types 1 and 2, Bovine enterovirus
Fungi: Saccharomyces cerevisiae
Certain cell cultures: Endoparasites of animals and humans (e.g., some nematodes)

This biosafety level covers laboratories that work with agents associated with human diseases (i.e. pathogenic or infections organisms) that pose a moderate health hazard.

Examples of typical BSL-2 biological material:

Bacteria: Chlamydia pneumoniae, Enterobacter spp., Mycoplasma pneumonia, Yersinia pseudotuberculosis

Viruses: Herpes simplex virus, HIV (when performing routine diagnostic procedures or working with clinical specimens

SL-3 laboratory typically includes work on microbes that are either indigenous or exotic, and can cause serious or potentially lethal disease through inhalation.
Examples of typical BSL-3 biological material:
Bacteria: Yersinia pestis, Brucella abortus, Chlamydia psittaci, Pseudomonas mallei
Viruses: West Nile fever, herpes B, hepatitis A

As the highest level of biological safety, a BSL-4 lab consists of work with highly dangerous and exotic microbes. Infections caused by these types of microbes are frequently fatal, and come without treatment or vaccines.
Examples of typical BSL-4 biological material:
Ebola-Virus, Lassa-Virus, Marburg-Virus

A preventive control plan (PCP) is a written document that demonstrates how hazards to your food are identified and prevented, eliminated or reduced to an acceptable level.
PCP Government of Canada

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size.
Safe Food for Canadians Regulations: Glossary of key terms

Current Good Tissue Practice

Chemical Indicator

Time necessary for converted BIT Solution™ to react and achieve maximum efficacy