Assessment Tool for Aseptic Compounding (ATAC) Definitions

Air quality strategy
A comprehensive plan designed to engineer a system of air supply that will achieve the required air quality classifications both on day 1 of operations and at regular times of monitoring and recertification.
Anteroom
A grade C (ISO class 8) space (or better) that provides access to the cleanroom for products and people. It is also where hand hygiene and garbing procedures occur.
[Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.]
Batch
Any quantity of a compounded preparation that is homogeneous within specified limits and is prepared according to a single production order.
Beyond-use date
The date (and time) after which the preparation shall not be used, stored, or transported. The time is calculated from the time compounding of the preparation begins. This term is not interchangeable with "expiration date".
[Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.]
Bubble-point test
A surrogate, non-destructive test performed to assess the integrity of filter in retaining bacteria. The test measures the amount of pressure required to produce a steady stream of bubbles through a wetted filter. The measured pressure is compared against the expected standard for the particular filter. If the measured pressure is less than the expected standard the filter failed the test.
[Integrity Testing Methods. Billerica, MA. EMD Millipore (Part of Merch KGaA, Darmstadt, Germany). https://www.emdmillipore.com/CA/en/product/Integrity-Testing-Methods,MM_NF-C537 ]
Changeover procedures
"A logical series of validated steps that ensures the proper cleaning of [work areas] and equipment before the [compounding] of a different [preparation] begins."
[Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa, ON: Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php.]
Cleaning agent
A substance that aids in the removal of organic matter, salts, and visible soil via a physical process (e.g., scrubbing or wiping) followed by rinsing with water.
[Buchanan EC. Cleaning and disinfecting. In: Buchanan EC, Schneider PJ, editors. Compounding sterile preparations. 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009. p. 289.]
Cleanroom
A room which is designed, constructed, and used in a way that controls the entry, production, and retention of airborne particles in the room to achieve a prescribed classification of air cleanliness based on the concentration of airborne particles.11
[Whyte W. Cleanroom technology: fundamentals of design, testing and operation. 2nd ed. Hoboken, NJ: John Wiley & Sons; 2010.]
Compounding activities
"The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available products. It can include reformulation to allow for a novel drug delivery. Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material."
[Policy on manufacturing and compounding drug products in Canada (POL-0051) Ottawa, ON: Health Canada; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/pol_0051-eng.php]
Controlled work area
"An enclosed workspace constructed and operated in such a manner and equipped with appropriate air-handling and filtration systems to reduce to a predefined level the introduction, generation and retention of contamination." [Quality Assurance of Aseptic Preparation Services, Beany, Ed.]
This area includes the anteroom, cleanroom, and hazardous drugs storage room or area. Also known as "controlled workspace".
Critical area
"That part of the controlled workspace where the aseptic manipulation is carried out. Particulate and microbiological contamination should be reduced to levels appropriate to the intended use." Also known as "critical zone". This term is not interchangeable with "critical site".
[Quality assurance of aseptic preparation services. 4th ed. Beaney AM, editor. London, UK: Pharmaceutical Press; 2006.]
Critical site
An exposed surface or opening at risk of direct contact with contaminated air, moisture, or of touch contamination.
This term is not interchangeable with "critical area".
[General chapter <797> pharmaceutical compounding — sterile preparations. In: USP on compounding: a guide for the compounding practitioner. Rockville, MD: United States Pharmacopeial Convention; 2014.]
Demarcation line
A line, real or virtual, that divides a physical area into at least 2 subsections. (In an anteroom, the "dirty side" of the demarcation line is where personnel don head covers and foot covers before crossing the demarcation line to the "clean side", where a surgical scrub is performed, appropriate garb is donned, and other appropriate measures are taken before entering the cleanroom.)
Disinfecting agent
An agent that kills bacteria, fungi, and viruses, reducing the microbial load on a surface.
[Buchanan EC. Personnel cleansing and garbing. In: Buchanan EC, Schneider PJ, editors. Compounding sterile preparations. 3rd ed. Bethesda, MD: American Society of Health-System Pharmacists; 2009. p. 293.]
Environmental monitoring strategy
A document that is used to inform monitoring and recertification of the environment (air and physical environment). The strategy includes a risk assessment, sampling plans (as well as which contamination sources and transmission routes are to be monitored), tests to be conducted and at what frequency, reports of all tests, conclusions drawn from all tests, processes for corrective action when test results suggest the environmental controls may have been compromised, and personnel responsibilities for executing the plan.
Family caregiver
Defined as family members and other significant people (as identified by the care recipient) who provide care and assistance to individuals living with a debilitating physical, mental or cognitive condition.
Similar terms: unpaid caregiver, informal caregiver
[Family caregiver (definition). Canadian Caregiver Coalition website: http://www.ccc-ccan.ca/]
First air
The air that leaves the HEPA filter in a unidirectional manner and is virtually free of particulate matter.
[General chapter <797> pharmaceutical compounding — sterile preparations. In: USP on compounding: a guide for the compounding practitioner. Rockville, MD: United States Pharmacopeial Convention; 2014].
High-alert drug
A drug that carries "a heightened risk of causing significant patient harm when they are used in error."
[ISMP. ISMP List of High-Alert Medications in Acute Care Settings. https://www.ismp.org/tools/highalertmedications.pdf]
Independent double check
An independent double check is a process in which a second practitioner conducts a verification. Such verification can be performed in the presence or absence of the first practitioner. In either case, the most critical aspect is to maximize the independence of the double check by ensuring that the first practitioner does not communicate what he or she expects the second practitioner to see, which would create bias and reduce the visibility of an error
[ISMP Canada Definitions: https://www.ismp-canada.org/definitions.htm]
Master formula
"A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls." Also known as a formula or recipe.
[Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa, ON: Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php]
Outer garment
Gown, coverall, trouser suit
Preparation dossier
A collection of information about a particular formulation of a preparation. It includes
a) reference name and number for the product dossier;
b) evidence demonstrating the added value of the preparation;
c) the master formula for the preparation, including, where appropriate, methods of quality control testing;
d) how to safely handle the preparation, including decontamination procedures (as relevant);
e) evidence supporting master formula; and
f) appropriate use of the product, including information for the patient and the prescriber.
[Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.]
Primary clean air device
A device (such as a cabinet, isolator, workbench or workstation) or room that provides a grade A (ISO class 5) environment for exposure of critical sites during the compounding of aseptic preparations. (Also known as a primary engineering control.)
[Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.]
Primary package
A container that comes into direct contact with the preparation (e.g., infusion bag, vial, or syringe).
[WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 9: Guidelines on packaging for pharmaceutical products In: WHO Technical Report Series, No. 902. In. Geneva, CH: World Health Organization; 2002]
Process validation program
A system of "establishing documented evidence with a high degree of assurance that a specific process consistently produces [a preparation] meeting predetermined specifications and quality characteristics." The validation may occur prospectively, concurrently, or retrospectively.
[Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa, ON: Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php]
Production record (also called a process record)
The documented evidence of the steps undertaken to compound a preparation.
Quarantine
The physical isolation of products from other products.
Respirator
A protective device worn to remove contaminants from the air or supply clean, breathable air from another source.
[Respirators. Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2004. Available from: http://www.cdc.gov/niosh/topics/respirators/default.html]
Secondary packaging
A container that comes into contact with the primary packaging of a preparation or product but does not come into direct contact with the preparation (e.g., an outer wrap containing at least one packaged preparation).
[Compounding: guidelines for pharmacies. Ottawa, ON. Canadian Society of Hospital Pharmacists; 2014.]
Stability test
An assessment of how the properties of a preparation change over time in specific conditions (e.g., temperature).1 The test includes assessing the specific attributes that are likely to affect the preparation in terms of its safety, quality, and/or efficacy; these attributes include the chemical (e.g., chemical integrity, potency), physical (e.g., homogeneity, suspension rate), microbiological (e.g., sterility), and toxicological properties of the preparation.2
1. General chapter <1191> stability considerations in dispensing practice. In: USP on compounding: a guide for the compounding practitioner. Rockville, MD: United States Pharmacopeial Convention; 2014.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Stability testing of new drug substance and products Q1A(R2). Geneva, CH1992 [revised 2003]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf.
Terminal sterilization
Sterilizing a drug in its final closed container.
[Health Canada GMP GUI-001]
Validated
"The documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment."
[Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa, ON: Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php]
Work-in-progress preparations
Preparations that are temporarily left as unfinished.