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)?

<p>The critical area within the PEC where critical sites are exposed to HEPA-filtered air (D)</p> Signup and view all the answers

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

<p>ISO Class 8 (B)</p> Signup and view all the answers

What type of equipment is characteristic of a PEC?

<p>Laminar Flow Clean Bench (LFCB) (A)</p> Signup and view all the answers

What is the primary purpose of a segregated compounding area?

<p>To prepare Category 1 CSPs and limit unnecessary items/ activities (C)</p> Signup and view all the answers

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

<p>Measure differential water pressure (C)</p> Signup and view all the answers

What is the recommended method for cleaning a HEPA filter?

<p>Saturate wipes with cleaner before use. (B)</p> Signup and view all the answers

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

<p>The top of the hood (B)</p> Signup and view all the answers

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

<p>The back of the hood (C)</p> Signup and view all the answers

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

<p>Plan the process to avoid leaving the hood unnecessarily (A)</p> Signup and view all the answers

Where should syringes be placed within the LFCB?

<p>With the needle/hub pointing towards the back of the hood. (B)</p> Signup and view all the answers

Where should IV bags be placed within the LFCB?

<p>With the injection site pointing towards the back of the hood. (C)</p> 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?

<p>6 inches (A)</p> Signup and view all the answers

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

<p>3 inches (C)</p> Signup and view all the answers

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

<p>Increased risk of cross-contamination between products (D)</p> 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?

<p>Class 7 area (B)</p> 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?

<p>To bring the air quality within the hood to ISO Level 5 (C)</p> Signup and view all the answers

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

<p>Every 30 minutes (B)</p> Signup and view all the answers

What is the first step when cleaning the LFCB?

<p>Low residue, water-based cleaner and disinfectant (B)</p> 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?

<p>Use sterile 70% isopropyl alcohol (IPA) (B)</p> Signup and view all the answers

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

<p>Using non-overlapping strokes, from clean-to-dirty (D)</p> 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?

<p>Whenever the hood has been moved, had scheduled maintenance, or suspected damage has occurred (A)</p> Signup and view all the answers

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

<p>Wear nail polish for aesthetics (C)</p> Signup and view all the answers

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

<p>Don mask and bonnet/cap (D)</p> Signup and view all the answers

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

<p>Maintaining silence to minimize contamination risk (C)</p> Signup and view all the answers

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

<p>Re-sanitize hands with gel-based sanitizer (D)</p> Signup and view all the answers

Barrier controls are primarily aimed at minimizing what risk?

<p>Cross contamination between personnel and CSPs (C)</p> Signup and view all the answers

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

<p>It must be discarded. (C)</p> Signup and view all the answers

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

<p>Rabbit test (D)</p> Signup and view all the answers

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

<p>Dispose directly into a red sharps container (A)</p> Signup and view all the answers

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

<p>The color of the packaging used (A)</p> Signup and view all the answers

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

<p>Double-check system (B)</p> Signup and view all the answers

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

<p>Internal self-assessment (D)</p> Signup and view all the answers

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

<p>Detailed spill protocols and proper labeling (C)</p> Signup and view all the answers

How often should storage conditions be monitored in the pharmacy?

<p>Daily in the pharmacy, and monthly at other locations (B)</p> Signup and view all the answers

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

<p>A recall protocol must be in place. (B)</p> Signup and view all the answers

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

<p>To ensure quality control and training for all personnel (C)</p> Signup and view all the answers

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

<p>They must be labeled appropriately and compared to records. (A)</p> Signup and view all the answers

Which procedure is recommended to validate sterilization methods?

<p>Biological indicators (A)</p> Signup and view all the answers

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

<p>The air closest to the front of a hood that is uncontaminated (A)</p> Signup and view all the answers

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

<p>Quantitative stability-indicating assays (B)</p> Signup and view all the answers

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

<p>A location where contamination can easily occur during compounding (D)</p> Signup and view all the answers

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

<p>To ensure sterility, stability, and purity (D)</p> Signup and view all the answers

Flashcards

Buffer Area

A controlled environment with at least ISO Class 7 air quality. It houses the PEC where sterile compounding takes place. It's designed to prevent contamination and prepare components for compounding.

Direct Compounding Area (DCA)

The area within the PEC where critical sites are directly exposed to HEPA-filtered air. This is where the actual sterile compounding happens.

Primary Engineering Control (PEC)

A designated space within the Segregated Compounding Area, at least ISO Class 5, that actively removes particles from the DCA with unidirectional airflow. It's essential for maintaining sterility.

Laminar Flow Clean Bench (LFCB)

A type of PEC that uses a specialized clean bench with a horizontal, vertical, or biological safety cabinet to create a clean environment for compounding. Containment isolators are also used.

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Segregated Compounding Area

A segregated area specifically for preparing Category 1 CSPs. It contains the PEC and restricts unnecessary items and activities to minimize the risk of contamination.

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Per-sterilization Procedures

Procedures for sterilizing high-risk products must be performed in an environment with at least ISO Class 8 air quality.

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PEC Placement

The PEC must be placed within the Buffer Area in a way that avoids any factors that could hinder its operation and maintain its effectiveness.

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Air Pattern Analysis

Regular smoke studies are used to ensure the PEC's air pattern is functioning correctly and effectively preventing contamination.

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Restricted Access Barrier System (RABS)

A type of hood creating an isolated environment, separate from room air, often in a segregated compounding area for preparing sterile products.

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Compounding Aseptic Containment Isolator (CACI)

A specific RABS type where the environment is fully enclosed and the internal air is separate from the surrounding environment. Often placed in a Class 8 area for compounding Category 2 or 3 products.

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Establishing Aseptic Field in a Hood

The air quality must reach ISO Level 5 before working in the hood. This is achieved by running the Laminar Flow Clean Bench (LFCB) for 15-30 minutes prior to use.

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Cleaning the LFCB

Regular cleaning is crucial for maintaining sterility. The LFCB should be cleaned before each shift, between products, and every 30 minutes during long processes.

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LFCB Cleaning Process (Step 1 & 2)

The hood should be cleaned using a low-residue, water-based cleaner to remove any dirt or drug residue, followed by sterile 70% isopropyl alcohol (IPA).

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LFCB Cleaning Process (Step 3)

When wiping the LFCB, always move from clean to dirty, using non-overlapping strokes. Clean surfaces are closest to the HEPA filter.

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LFCB Maintenance: Pre-filters

The LFCB's pre-filters need to be changed monthly.

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LFCB Maintenance: HEPA Filters

The HEPA filter needs to be changed every 6 months or whenever the hood has been moved, maintained, or damaged, like accidental impacts or exposure to liquids.

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Staging Supplies

The process of arranging supplies within the laminar flow clean bench (LFCB) to minimize contamination and ensure efficient compounding.

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Critical Sites in First Air

Critical sites of supplies should be positioned facing the back of the LFCB to maintain a clean environment.

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Supplies Placement

Avoid placing supplies directly in front of each other to prevent contamination from downstream air.

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Syringe Placement

Syringes should be positioned with the needle pointing towards the back of the LFCB to minimize contamination risks.

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IV Bag Placement

IV bags should be placed with the injection site facing the back of the LFCB or hung from the IV pole (in a HFCB only). This placement ensures a sterile injection site.

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Distance from Hood Edges

Supplies should be placed at least 6 inches away from the front of the hood and 3 inches from the sides/back to avoid disrupting airflow and causing contamination.

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Spacing Between Supplies

Supplies should be spaced at least 3 inches apart to allow for easy access and prevent contamination from disrupted airflow.

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LFCB Cleaning Protocol

The LFCB should be cleaned from the top (HFCB) or the back (VFCB) to prevent cross-contamination. Different protocols apply for hazardous substances.

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Barrier Controls

Barrier controls are processes that minimize the risk of contamination between the compounder and sterile products. Simple measures make a big difference, like personal hygiene rules and proper hand scrubbing and garbing procedures.

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Hand Scrubbing and Garbing

Hand scrubbing and garbing involves a specific procedure to disinfect hands and put on sterile protective clothing before entering the compounding area.

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Personnel Controls

Personnel controls are systems that ensure the sterility of compounded sterile products (CSPs) is maintained. This includes the behaviors and skills of the compounding personnel.

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Sterile Compounding: Maintaining a Sterile Environment

The key to sterile compounding is maintaining a sterile environment and avoiding contamination. It's like keeping the 'sterility bubble' intact.

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Personal Hygiene in Sterile Compounding

Important personal hygiene practices include avoiding jewelry, makeup, nail polish, and unnecessary talking. This helps prevent contamination from the compounder to the medications.

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Stability Testing

Quantitative stability-indicating assays are recommended to assess the stability of compounded sterile products over time. These assays measure the drug's active ingredient and degradation products, ensuring its potency and safety.

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Sterilization Method Validation

The sterilization method used for compounded sterile products must be validated using biological indicators. This ensures the method effectively kills all microorganisms, guaranteeing sterility.

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Final Product Quality Assurance

Before releasing a compounded sterile product, it undergoes a visual inspection. This includes checking for particulates, discoloration, leakage, and overall appearance. The order, compounding procedures, and records are also reviewed.

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Double-check System

A 'double-check' system ensures accuracy in compounding. Two different individuals independently verify the ingredients, volumes, and procedures, minimizing errors.

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Sterility Testing

Sterility tests are crucial to confirm that compounded products are free of any living microorganisms. Direct inoculation and membrane filtration are common methods.

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Endotoxin Test

The Limulus Amoebocyte Lysate (LAL) Assay is a sensitive test used to detect bacterial endotoxins, which are harmful substances found in some bacteria.

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Particulate Matter Test

Particulate matter tests ensure that compounded products are free from any visible particles. Light obscuration and microscopy are used to detect these particles.

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Product Recall Protocol

If sterile products are dispensed before sterility test results are available, a protocol must be in place for recalling the product and notifying patients and physicians.

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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
  • 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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