Glossary
A
ADC
Antibody-drug conjugates
Antibody-drug conjugation technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. In conjugated form, HPAPIs exhibit selective cytotoxicity which help spare non-target cells from toxic effects, thereby improving the overall safety profile of the therapy for the patient.
AHU
Please see HVAC.
Aseptic processing
Is the process by which a sterile (aseptic) product (typically food or pharmaceutical) is packaged in a sterile container in a way that maintains sterility.
Antiseptics
Are used to prevent infection by killing or inhibiting the growth of microorganisms. Because these products are used in or on humans or animals, they are considered drugs and are approved and regulated by FDA.
API
An active ingredient (AI) is the ingredient in a pharmaceutical drug that is biologically active. The similar terms active pharmaceutical ingredient (API) and bulk active are also used in medicine, and the term active substance may be used for natural products.
AQL
Acceptance Quality Limit in QC (Quality Control) inspections.
A & E firm
A rchitecture and E ngineering firm offering project planning-, project management-, engineering and design- support.
B
Batch
manufacturing means a specific quantity of a drug that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
BI
B iological I ndicator used for e.g cycle development / cycle validation in Isolators (for example Mesa Labs: geobacillus stearothermophilus ).
Bioburden
is normally defined as the number of bacteria living on a surface that has not been sterilized. The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes.
BSL-1..4
BSL-1: Bio Safety Level 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. An example of a microbe that is typically worked with at a BSL-1 is a nonpathogenic strain of E. coli.
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 agents typically worked with in a BSL-2 include equine encephalitis viruses and HIV, as well as Staphylococcus aureus (staph infections).
BSL-3: Again building upon the two prior biosafety levels, a BSL-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 microbes worked with in a BSL-3 includes; yellow fever, West Nile virus, and the bacteria that causes tuberculosis.
BSL-4: BSL-4 labs are rare. However some do exist in a small number of places in the US and around the world. 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. Two examples of such microbes include Ebola and Marburg viruses.
C
Campaign
Campaign manufacture as being a separation in time of production. That is, manufacturing a series of batches of the same product in sequence in a given period of time and/or maximum number of batches followed by an appropriate (validated) cleaning procedure.
CI
C hemical I ndicator used for e.g cycle development / cycle validation in Isolators.
CFU
A c olony f orming u nit ( CFU ) is a unit used 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.
Compounding
Compounding is the creation of a pharmaceutical preparation - a drug - by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. ... Flavor a medication (to make it more palatable for a child or a pet). ... It's tailored to a patient.
Cytotoxic
Cytotoxicity is the quality of being toxic to cells and cell-killing. Chemotherapy and radiotherapy are forms of cytotoxic therapy.Cytotoxic drugs (sometimes known as antineoplastics) describe a group of medicines that contain chemicals which are toxic to cells, preventing their replication or growth, and so are used to treat cancer. They can also be used to treat a number of other disorders such as rheumatoid arthritis and multiple sclerosis.
CMO / CDMO
A contract manufacturing organization ( CMO ), sometimes called a contract development and manufacturing organization ( CDMO ), is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows major pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead. Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production. CMOs are contract manufacturers, but they can also be more than that because of the development aspect.
D
D-Value
In microbiology, D-value refers to decimal reduction time and is the time required at given conditions (e.g. temperature, H2O2 concentration, humidity, pressure, .. ), to kill 90% (or 1 log) of the exposed microorganisms.
DEHS / DOP
or simple filter integrity testing, is the process in which the integrity of your HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Penetration Air) filter is tested through the introduction of particulates.
Oil is dispersed as an aerosol into the upstream flow of the filter media while the number of particles in the downstream flow is measured using a calibrated photometer.
These solutions generate a gas type smoke and then generate gas particles that will be greater than 0,3 µm. The test will certify the HEPA filter is fully functioning and there is no leakage or damage.
Di-Ethyl-Hexyl-Sebacat (DEHS) is a no soluble, colourless and odourless liquid which is suitable for producing steady aerosols. It is used to perform HEPA filter integrity testing.
Dioctyl Phthalate (DOP) testing is a very quick process that tests the integrity of the HEPA (High Efficiency Particulate Air) filter using DOP solutions in their operational conditions.
DOP is a liquid chemical which produces mono or poly dispersed test aerosol of subparticles, generated to challenge (evaluate integrity) of HEPA Filters.
DOP is no longer widely used for HEPA integrity Testing in our industry. DOP was determined to be a carcinogen and has been replaced in most test applications.
Dosage From
Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose.
E
Endotoxins
a heat-stable toxin associated with the outer membranes of certain gram-negative bacteria, including Brucella, Neisseria, and Vibrio species. Endotoxins are not secreted but are released only when the cells are disrupted; they are less potent and less specific than the exotoxins; and they do not form toxoids. In large quantities they produce hemorrhagic shock and severe diarrhea; smaller amounts cause fever, altered resistance to bacterial infection, leukopenia followed by leukocytosis, and numerous other biologic effects.
Exotoxins
a potent toxin formed and excreted by the bacterial cell and found free in the surrounding medium; exotoxins are the most poisonous substances known. They are protein in nature and heat labile, and are detoxified with retention of antigenicity by treatment with formaldehyde. Bacteria of the genus Clostridium are the most frequent producers of exotoxins; diphtheria, botulism, and tetanus are all caused by such toxins.
E-beam (tunnel)
Electron-beam (e-beam tunnel) radiation that decontaminates the outer surfaces of the tubs containing pre-sterilized syringes (and other containers) is generally seen as a best practice solution for high-speed filling lines. ...The tubs move on a conveyor belt through the electron cloud generated by the e-beam emitters.
F
FS
Functional Specification
(Pharmaceutical) Formulation
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.
G
Geobacillus stearothermophilus
is a gram positive thermophilic (heat loving) bacteria characterized by a inner cell membrane and a thick cell wall. This bacteria is mostly used for BIs in Isolator for CD/CV.
Gram-positive bacteria
are bacteria that give a positive result in the Gram stain test, which is traditionally used to quickly classify bacteria into two broad categories according to their cell wall.
Gram-negative bacteria
are a group of bacteria that do not retain the crystal violet stain used in the gram-staining method of bacterial differentiation. They are characterized by their cell envelopes, which are composed of a thin peptidoglycan cell wall sandwiched between an inner cytoplasmic cell membrane and a bacterial outer membrane.
H
HDS
Hardware Design Specification
HPAPI or API
high-potency
active pharmaceutical ingredients
HVAC
AHU , which is A ir H andling U nit is an appliance used to circulate air. HVAC is Heating, V entilating and A ir C onditioning system. HVAC is the central unit to which AHU is connected.
HVAC here mainly refers to the technology of pharmaceutical environmental control. The H eating, V entilating and A ir C onditioning system uses the principles of fluid mechanics, thermodynamics and heat transfer. HVAC is used to condition the atmosphere in facilities and barrier systems like Isolators.
HVAC systems play a crucial role in pharmaceutical engineering and manufacturing because they have a direct impact on the production environment. Optimized HVAC units can help pharmaceutical companies manage airborne contaminants, pass inspections, and remain CGMP-compliant, and more.
HEPA filter
High Efficiency Particulate Air filter
I
IQ
Installation Qualification
IPA
Isopropyl Alcohol is an organic compound with the formula (CH3)2CH(OH). This clear, colorless liquid is widely used as a solvent.
J
K
L
Log 6 reduction
A validated process used to render a product free of viable organisms. In a sterilization process, the nature of microbiological death or reduction is described by an exponential function. Therefore, the number of microorganisms which survive a sterilization process can be expressed in terms of probability. Log 6 reduction means a kill rate of 99,9999% or survival 1 of 1000000.
LHSKP
The Limited Holcomb-Spearman-Karber Procedure (LHSKP) ist a method to determine the appropriate decontamination phase time in Isolators.
M
N
O
OQ
Operational Qualification
OSD
Oral Solid Dosage (most in form of tablets, capsules, pills, pastilles, powder,..)
OSHA
Occupational Safety and Health Administration.
OEB
Occupational Exposure Band (i.e. in levels of 1... 6). In an Occupational Exposure Band several adjacent OELs are grouped to a band. For the OEB classification exist several national standards as well as classifications developed within different companies
Wikipedia: It´s a process intended to quickly and accurately assign chemicals into specific categories (bands), each corresponding to a range of exposure concentrations designed to protect worker health.
OEL
The OEL (i.e. in 3 ) determines to which limit an operator can be exposed to a certain product on average during one shift (8 hours) without affecting health. Those values can be binding by law or just recommendations. Therefore the Occupational Exposure Limits may vary for the same product depending on location or company.
Wikipedia: Occupational Exposure Limit is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials. It is typically set by competent national authorities and enforced by legislation to protect occupational safety and health.
P
PQ
Performance Qualification
PQS
Pharmaceutical Quality System
PreVAS
PreVAS stands for "pre-Validated", "pre-Assembled" and "pre-Sterilized".
Pyrogens
A polypeptide injected into humans - in sufficient amount - that produces fever by causing metabolic changes in the hypothalamus. Pyrogens are either exogenous (produced by infectious agents) or endogenous (produced by cells in the body such as macrophages).
PNSU
Probability of a Non Sterile Unit.
PPE
Personal Protective Equipment.
Q
R
RABS
Restricted Access Barrier Systems incorporates a "barrier" with HEPA filtered airflow to significantly reduce the "Probability of a Non Sterile Unit" (PNSU).
S
SDS
Software Design Specification
SMDS
Software Modul Design Specification
SAL
In microbiology, Sterility Assurance Level (SAL) is the probability that a single unit that has been subjected to sterilization nevertheless remains non-sterile.
It is never possible to prove that all organisms have been destroyed, as the likelihood of survival of an individual microorganism is never zero.
T
TOC
Total organic carbon ( TOC ) is the amount of carbon found in an organic compound and is often used as a non-specific indicator of water quality (e.g. WFI) or cleanliness of pharmaceutical manufacturing equipment.Ensuring that the purity of the water helps to eliminate the impact that bacteria and other organic compounds may have on product quality. Organic compounds combine with other elements to produce molecules that can prove harmful to products and to the environment once the water is discharged. Mostly this is done together wit conductivity testing in pure media supply.
Traceability Matrix (RTM)
The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. ... The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.