Glossary of Terms

Pharmaceutical, Life Sciences & Healthcare.

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There are currently 13 names in this directory beginning with the letter C.
CAP Audit
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.

Cleanroom Apparel/Garments/Clothing
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.

Cleanroom classification – Grade A, B, C or D
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.

Cleanroom classification – ISO Class
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.

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

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

Cleanroom Facility - In Operation
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.

Biosecurity - Laboratory Biosafety

All | C I L P S
There are currently 9 names in this directory
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.

Laboratory Biosafety level 1 (BSL-1)
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)

Laboratory Biosafety level 2 (BSL-2)
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

Laboratory Biosafety level 3 (BSL-3)
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

Laboratory Biosafety level 4 (BSL-4)
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

Steramist - iHP Fogging

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There are currently 18 names in this directory
Aeration Time
Period in which H2O2 is actively removed from the treated room

Application Time
Time it takes to physically apply BIT Solution

Biological Indicator, a validation method

Binary Ionization Technology®

BIT Solution
7.8% H2O2 sole ingredient mixture

Current Good Tissue Practice

Chemical Indicator

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

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

DI Water
Deionized Water

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

Amount of BIT Solution™ delivered during application

Environmental Protection Agency

Learn more about EPA

U.S. Food and Drug AdministrationLearn more about FDA

Ionized Hydrogen Peroxide

Reactive Oxygen Species are formed as a natural byproduct in atmospheric chemistry. The Hydroxyl Radical is a ROS. 

SteraMist™ disinfection and decontamination is an EPA-registered solution and equipment combination fogger featuring a 7.8% hydrogen peroxide sole active ingredient. SteraMist brings you unparalleled material compatibility with a wide variety of use sites. The use of ionized Hydrogen Peroxide (iHP) technology creates natural, powerful particles that spread throughout large and small areas, reaching the toughest spots and goes far beyond manual cleaning and other disinfection methods.
SteraMist® is an EPA registered sole active ingredient Hydrogen Peroxide based product line that uses Binary Ionization Technology (BIT™).

TOMI™ Environmental Solutions, Inc. is a global bacteria decontamination and infectious disease control company, providing environmental solutions for indoor surface decontamination through the manufacturing, sales and licensing of its SteraMist® brand products. TOMI Environmental Solutions, Inc.