Sterile Dosage: Aseptic Technique Flashcards

Questions and Answers

What is the maximum number of particles allowed in an ISO Class 5 area?

3,520 (correct)

352,000

100

3,520,000

What is an ISO Class 7 area characterized by?

No more than 3,520 particles per cubic meter

No more than 3,520,000 particles per cubic meter

No more than 352,000 particles per cubic meter (correct)

No more than 100 particles per cubic meter

What is the purpose of a buffer area?

Usually an ISO Class 7 area where the laminar flow hood is located.

Define Critical Site in sterile compounding.

Any opening or surface that can provide a pathway between the sterile product and environment. Signup and view all the answers

What are the Garbing Steps listed from dirtiest to cleanest?

Shoe covers, hair covers, face mask, hand cleansing, hand washing, dry hands, non-shedding gown, gloves, IPA70 on gloves Signup and view all the answers

The airflow in a laminar flow workbench moves ______.

in a single direction Signup and view all the answers

The Golden Rule states that nothing should come between the Critical Site and HEPA filter.

True Signup and view all the answers

What does HEPA filter remove?

Particles 0.3 microns and larger. Signup and view all the answers

What constitutes Bioburden?

It should be as low as possible. Signup and view all the answers

What does USP Chapter 797 entail?

Microbiological evaluation of clean rooms Signup and view all the answers

Which class will contain no more than 100 particles per cubic foot of air?

FDA Class 100 Signup and view all the answers

Study Notes

Sterile Dosage: Aseptic Technique

ISO Class 5 Area: Maximum of 3,520 particles per cubic meter (0.5 microns and larger).
ISO Class 7 Area: Maximum of 352,000 particles per cubic meter (0.5 microns and larger).
ISO Class 8 Area: Maximum of 3,520,000 particles per cubic meter (0.5 microns and larger).
Buffer Area: Typically an ISO Class 7 area housing the laminar flow hood, maintaining positive pressure and supplied with HEPA-filtered air.
Antearea: An ISO Class 8 or better space designated for hand hygiene, garbing, component staging, and other activities generating particulates.
Garbing Steps: Sequence from dirtiest to cleanest—shoe covers, hair covers, face mask, hand cleansing/washing, drying hands, non-shedding gown, gloves, and IPA70 application on gloves.
Laminar Flow Workbench Functionality: Draws air through a pre-filter, pressurizes it in a plenum for even distribution to HEPA filter, blowing air across the work surface toward the operator; vertical configurations are used for hazardous compounding.

Sterile Compounding Requirements

Key Requirements: Maintain ISO classified air environments, proper personnel garbing and gloving, monitor environmental quality.

Buffer and Antearea Creation

Buffer Area Creation: Needs positive pressure of 0.02-0.05 inches water, HEPA filtered air at 30 changes/hour, and features smooth surfaces without cracks or seams; sinks/drains are prohibited.
Antearea Creation: Non-porous surfaces with a clear line of demarcation, avoiding cracks and seams.
Primary Engineering Control (PEC): Devices such as laminar airflow workbenches or biological safety cabinets that provide an ISO Class 5 environment.

Airflow and Particle Standards

Unidirectional Flow: Air moving in a single direction at 90 ft/min ± 20% to keep critical processing areas clear of particles.
Sterility Definition: State of being free from all living organisms.
Critical Site: Any opening or surface that can connect sterile products to the environment.
Golden Rule: Ensure nothing comes between the critical site and HEPA filter.

Particle Standards

FDA and ISO Classifications:
- ISO Class 5 (FDA Class 100): ≤ 3,520 particles/m³
- ISO Class 7 (FDA Class 10,000): ≤ 352,000 particles/m³
- ISO Class 8 (FDA Class 100,000): ≤ 3,520,000 particles/m³

Certification and Standards

Certification Frequencies: ISO Classes and personnel are re-evaluated every 6 months for high-risk and every year for low/medium-risk personnel.
Bioburden Management: Aim for minimal presence; involves proper garbing, cleanroom conduct, and sanitization prior to access.
Media Fill Testing: Assesses aseptic skills before preparing compounded sterile preparations (CSPs), conducted at least annually under worst-case conditions.

Compounding Risks and Challenges

Common Issues in Compounding: Problems often arise from poor leadership, garbing techniques, hygiene, inadequate cleaning, and failure to maintain controls.

Filter and Dose Specifications

HEPA Filters: Effectively remove particles ≥ 0.3 microns; acceptable leak rate is 0.01%, and patches must not exceed 5%.
Single Dose: Contains no preservatives; usable for up to 6 hours post-opening in ISO Class 5 (e.g., ampules).
Multiple Dose: Contains preservatives; use permissible for 28 days with multiple entries.

Sanitization and Standards

Sanitization Agents: Remove many but not all organisms.
USP Chapter 797: Sets standards for cleanroom microbiological assessment; outlines requisite testing, personnel training, and sampling protocols.
Personnel Training: Essential practices include hand hygiene, garbing, and glove use, verified via fingertip sampling for CFU.

Description

Test your knowledge of aseptic technique with these flashcards focused on ISO classifications. Each card provides a definition of different ISO class areas used in sterile dosage. Perfect for students and professionals in the pharmaceutical and healthcare fields.