Biosecurity

All | C I P S
There are currently 4 names in this directory
CDC
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
CDC Environmental Cleaning and Disinfection Recommendations

IATA
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

PCP
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

SFCR
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

All | A B C D E F I R T
There are currently 17 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

BI
Biological Indicator, a validation method

BIT
Binary Ionization Technology®

BIT Solution
7.8% H2O2 sole ingredient mixture

CGTP
Current Good Tissue Practice

CI
Chemical Indicator

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

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

DI Water
Deionized Water

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

Dose
Amount of BIT Solution™ delivered during application

EPA
Environmental Protection Agency

Learn more about EPA https://www.epa.gov/


FDA
U.S. Food and Drug Administration Learn more about FDA https://www.fda.gov/

iHP
Ionized Hydrogen Peroxide

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

TOMI
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. SteraMist® is an EPA registered sole active ingredient Hydrogen Peroxide based product line that uses Binary Ionization Technology (BIT™). TOMI Environmental Solutions, Inc.

Pharmaceutical, Life Sciences & Healthcare.

All | A B C D F G H I L M N P R S U V
There are currently 35 names in this directory
Air Velocity
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).

Airflow
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.

Airflow Uniformity
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).

API
Active Pharmaceutical Ingredient

BSC
Biosafety cabinet —also called a biological safety cabinet or microbiological safety cabinet

CDMO
Contract Development Manufacturing Operations

Cleanroom
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.

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

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

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

GDP
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.

GMP
Good Manufacturing Practice -GMP is also sometimes referred to as "cGMP". The "c" stands for "current"

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

iHP™
Ionized Hydrogen Peroxide

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

Laminar Air Flow
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.

Micron
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.

NAPRA
National Association of Pharmacy Regulatory Authorities

Particle Count
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.

PPE
Personal Protective Equipment

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

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

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

Shutdown management
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

SOPs
Standard Operating Procedures

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

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

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