Pharmaceutical Compounding Standards Quiz

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Questions and Answers

Which ISO class is required for the buffer area?

ISO Class 5

ISO Class 6

ISO Class 7 (correct)

ISO Class 8

What is the primary purpose of the buffer area?

To serve as a critical area for compounding sterile preparations.

To house the PEC and personnel.

To provide the final packaging line for sterile products.

To act as a staging and preparation area for compounding components. (correct)

What is a key characteristic of airflow within a Primary Engineering Control (PEC)?

Turbulent and varied

Naturally ventilated

Unidirectional and high velocity (correct)

Low velocity, multidirectional

What establishes the Direct Compounding Area (DCA)?

The critical area within the PEC where critical sites are exposed to HEPA-filtered air Signup and view all the answers

What is the minimum ISO classification required for performing per-sterilization procedures for high risk products?

ISO Class 8 Signup and view all the answers

What type of equipment is characteristic of a PEC?

Laminar Flow Clean Bench (LFCB) Signup and view all the answers

What is the primary purpose of a segregated compounding area?

To prepare Category 1 CSPs and limit unnecessary items/ activities Signup and view all the answers

What is one of the methods used to verify proper operating pressure within the buffer area?

Measure differential water pressure Signup and view all the answers

What is the recommended method for cleaning a HEPA filter?

Saturate wipes with cleaner before use. Signup and view all the answers

When cleaning a Horizontal Flow Clean Bench (HFCB), which part should be cleaned first?

The top of the hood Signup and view all the answers

When cleaning a Vertical Flow Clean Bench (VFCB), which part should be cleaned first?

The back of the hood Signup and view all the answers

What is a crucial step to perform before beginning compounding inside a Laminar Flow Clean Bench (LFCB)?

Plan the process to avoid leaving the hood unnecessarily Signup and view all the answers

Where should syringes be placed within the LFCB?

With the needle/hub pointing towards the back of the hood. Signup and view all the answers

Where should IV bags be placed within the LFCB?

With the injection site pointing towards the back of the hood. Signup and view all the answers

What is the minimum distance supplies should be kept from the front edge of the LFCB to prevent airflow disruption?

6 inches Signup and view all the answers

What is the minimum distance supplies should be kept from the sides/back of the LFCB?

3 inches Signup and view all the answers

What is a key concern when working directly within the smoke split of a laminar flow hood?

Increased risk of cross-contamination between products Signup and view all the answers

In which area should a Restricted Access Barrier System (RABS) be placed for compounding Category 2 or 3 products?

Class 7 area Signup and view all the answers

What is the primary reason for running the Laminar Flow Clean Bench (LFCB) for 15-30 minutes prior to use?

To bring the air quality within the hood to ISO Level 5 Signup and view all the answers

What is the recommended frequency for cleaning the LFCB during a long and complex compounding process?

Every 30 minutes Signup and view all the answers

What is the first step when cleaning the LFCB?

Low residue, water-based cleaner and disinfectant Signup and view all the answers

In the cleaning process of an LFCB, after cleaning with a water-based cleaner and disinfectant, what should be the next step?

Use sterile 70% isopropyl alcohol (IPA) Signup and view all the answers

How should the LFCB be wiped when cleaning, to ensure proper aseptic technique?

Using non-overlapping strokes, from clean-to-dirty Signup and view all the answers

When should the HEPA filter of a Laminar Flow Clean Bench (LFCB) be changed, in addition to the scheduled 6 month change?

Whenever the hood has been moved, had scheduled maintenance, or suspected damage has occurred Signup and view all the answers

Which of the following is NOT a recommended practice for personal hygiene in barrier controls?

Wear nail polish for aesthetics Signup and view all the answers

What is the first step in the garbing procedures for compounding personnel?

Don mask and bonnet/cap Signup and view all the answers

Which of the following behaviors is recommended during the compounding process?

Maintaining silence to minimize contamination risk Signup and view all the answers

What should personnel do after scrubbing their hands in the garbing process?

Re-sanitize hands with gel-based sanitizer Signup and view all the answers

Barrier controls are primarily aimed at minimizing what risk?

Cross contamination between personnel and CSPs Signup and view all the answers

What should happen if an item cannot be validated, verified, or identified during compounding?

It must be discarded. Signup and view all the answers

Which quality control test is considered the most outdated for testing pyrogens?

Rabbit test Signup and view all the answers

What is the correct method to dispose of needles after compounding?

Dispose directly into a red sharps container Signup and view all the answers

Which factor is NOT considered when evaluating the transport mechanism for compounded sterile preparations (CSP)?

The color of the packaging used Signup and view all the answers

What kind of system is recommended to be used before releasing a final compounded product?

Double-check system Signup and view all the answers

Which of the following is NOT a recommended quality assurance protocol for final product inspection?

Internal self-assessment Signup and view all the answers

What should be included with the transport of chemo/radiopharmaceuticals?

Detailed spill protocols and proper labeling Signup and view all the answers

How often should storage conditions be monitored in the pharmacy?

Daily in the pharmacy, and monthly at other locations Signup and view all the answers

What is required if products are dispensed before the results of sterility testing are received?

A recall protocol must be in place. Signup and view all the answers

What is the purpose of developing Standard Operating Procedures (SOPs) in CSP?

To ensure quality control and training for all personnel Signup and view all the answers

What should be checked to ensure the identity and quality of compounded sterile products (CSPs)?

They must be labeled appropriately and compared to records. Signup and view all the answers

Which procedure is recommended to validate sterilization methods?

Biological indicators Signup and view all the answers

What does 'first air' refer to in contamination control?

The air closest to the front of a hood that is uncontaminated Signup and view all the answers

What should be performed to assess the moisture content upon storage of compounded products?

Quantitative stability-indicating assays Signup and view all the answers

Which of the following describes 'critical site' in sterile compounding?

A location where contamination can easily occur during compounding Signup and view all the answers

Professional judgment is required when re-dispensing unused CSPs for which reason?

To ensure sterility, stability, and purity Signup and view all the answers

Study Notes

Aseptic Processing Objectives

Define aseptic processing
Define/describe control measures used in aseptic processing
List steps/methods needed for effective aseptic processing
Describe basic compounding equipment usage with aseptic controls

References and Resources

Elder (2018): Chapter 32, General Principles of Sterile Dosage Form Preparation (in A Practical Guide to Contemporary Pharmacy Practice, 4th ed.)
McKeon and Peters (2001): Valiteq™ Aseptic Technique Validation System: Compounding Manual, 2nd ed.
Ochoa and Vega (2015): Concepts in Sterile Preparations and Aseptic Technique, 1st ed.

Quality Assurance: Environmental and Engineering Considerations

Sites preparing CSPs need formal, written QA programs
Activities must be monitored, evaluated, corrected, and improved in a timely fashion
Protection of critical sites (preventing physical contact/airborne contamination) is a top priority in sterile compounding

Methods of Controlling Contamination

Engineering controls: facility design (flooring, ceilings, shelving, HVAC systems, sink placement)
Barrier controls: items that block contaminant transfer (personal hygiene, hand scrubbing, gloves, booties, masks, gowns)
Personnel controls: systems managing CSP manipulation to minimize contaminants during compounding

Engineering Controls

Devices for air purity (laminar flow hoods, heating/cooling systems, clean room architecture)
Specifications: comfort, smooth/impervious surfaces, resistant to disinfectants, and non-essential equipment outside the buffer zone/segregated compounding area

ISO Air Purity Standards

Table providing ISO classes, maximum particles/m³, and equivalent Federal Standard

Ante Area

At least ISO Class 8 under "dynamic" conditions
Primarily for hand cleansing, garbing, staging components, labeling, and activities generating high particulates
Transition area maintaining pressure for airflow

Buffer Area

At least ISO Class 7
Contains Primary Engineering Control (PEC)

Secondary Engineering Controls (PEC)

Unidirectional airflow, sweeping particles from the DCA
Located in a buffer area, and is continuously monitored or physically separated to maintain at least 0.02-0.05 inch water positive pressure differential
Includes specific setups like Laminar Flow Clean Benches (LFCBs), horizontal/vertical biological safety cabinets, or compound aseptic containment isolators

Direct Compounding Area (DCA)

ISO Class 5
Space restricted to preparing Category 1 CSPs.
Restricts items/activities unnecessary for sterile compounding

Environmental Sampling

Periodic environment sampling using qualified personnel for potential contamination
Following new equipment/facility certification and maintenance, patient-related infections, and service/repair issues
Procedures for non-viable particle testing using electronic particle counters/air membrane filtration
Pressure differential monitoring to ensure positive pressure from buffer to ante area (or negative pressure for hazardous substances)
Testing for viable/airborne particles using impact methods, electronic devices, and plates

Recommended Action Levels for Microbial Contamination

Table correlating ISO class with acceptable air samples

Cleaning and Disinfection

USP <797> guidelines for cleaning/disinfection of engineering controls, compounding supplies, and personnel
Procedures for Ante Area/Buffer Zone/PEC
Cleaning frequency: PEC at beginning/end of each shift, within 30 minutes of previous disinfection, after spills, and following suspected contamination
Cleaning frequencies for counters/work surfaces, floors, walls

Laminar Flow Cleanbench (LFCB)

HEPA filtered air, unidirectional, ISO Class 5 or better
First air directly from HEPA filter
Critical sites kept at the highest level of cleanliness, physically untouchable for first-air contact
Methods to avoid disrupting airflow

Horizontal/Vertical Flow Cleanbenches (HFCB/VFCB)

Airflows from back (HEPA filter) exiting from the front
Prevent airflow disruption & repeated hand movement/insertion into the hood (ex. avoid placing hands behind critical sites)

Biological Safety Cabinet (BSC)

Specialized VFCBs for hazardous substances (Class II)
Airflow protects product and personnel from contamination
Avoid placing hands above critical sites

Restricted Access Barrier Systems (RABS): Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), Pharmaceutical Isolator

"Glove box" providing isolated environment
Different RABS units corresponding to Category 2 or 3 and Class 7 or Class 8 areas for compounding

Preparing to Work

Verifying operational conditions (LFCB) before compounding. Including: pressure differentials, pre-filter and HEPA filter maintenance frequency (every 6 months)
Establishing the Aseptic Field - Air quality to ISO Level 5

Cleaning the LFCB

Low residue, water-based cleaner/disinfectant, followed by sterile 70% isopropyl alcohol (IPA), wiping clean to dirty, and avoiding spraying cleaner near the HEPA filters
Procedure variations for HFCB/VFCB

Staging Supplies

Choosing proper equipment, preventing downstream contamination

Barrier Controls

Preventing cross-contamination between compounder and CSPs.
Personal hygiene practices (no jewelry, no makeup, hair covered, no unnecessary talking).
Maintaining proper placement (within 6 inches of front and back, within 3 inches of sides) to ensure airflow isn't disrupted

Hand Scrubbing and Garbing

Institutional handwashing protocols, donning gowns (chemo-resistant) / sterile gloves.
Other PPE, e.g., goggles, face mask, respirator, as needed.

Personnel Training

Topics: hygiene, garbing, aseptic manipulation, cleaning/disinfection
Competency requirements: didactic training, written competency assessment, skills assessment (media fill, etc.)
Evaluation due every 12 months

Competency Evaluations & Action Levels

Personnel must pass separate garbing/aseptic manipulation competency assessments
Garbing assessments include visual observation of hand hygiene and garbing procedures
Aseptic manipulation assessments include media fill testing and surface sampling of direct compounding areas
Each competency must be completed every 6 months (Category 1 or 2) or 3 months (Category 3) thereafter

Compounding Policies & Procedures

QA protocols for quality assurance: item validation/verification, quantitative stability assays, sterility tests, NO food/drinks/biologic fluids into compounding area

Final Product Quality Assurance

Visual inspection (particulates, discolouration, leakage), review of order/procedures/compounding records, and thorough materials check
Compliance with "double-check system" and avoidance of discarding until verification/inspection is complete
Quality Control Tests to be performed before release

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Description

Test your knowledge on the ISO classifications and standards related to pharmaceutical compounding areas. This quiz covers key characteristics of airflow, cleaning protocols, and setup requirements for sterile environments. Ideal for those studying pharmacy or compounding techniques.