Regulatory aspects of isolation/barrier technology

Related Experiment Video

Updated: Nov 6, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

J C Lyda1

  • 1External and Regulatory Affairs, PDA, Bethesda, Maryland, USA.

PDA Journal of Pharmaceutical Science and Technology
|November 1, 1995
PubMed

More Related Videos

Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 1. Biosafety Level 4 Suit Laboratory Suite Entry and Exit Procedures09:54

Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 1. Biosafety Level 4 Suit Laboratory Suite Entry and Exit Procedures

Published on: October 3, 2016

Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 3. Aerobiology11:13

Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 3. Aerobiology

Published on: October 3, 2016

Related Concept Videos

Transmission-based Precautions II: Airborne and Protective Environment01:25

Transmission-based Precautions II: Airborne and Protective Environment

Transmission-based precautions are for patients infected or suspected to be infected (or colonized) with organisms posing a significant risk to others. The transmission precautions include airborne and protective environment precautions.
Airborne precautions:
Use airborne precautions when treating patients known or suspected to have diseases that spread through the air—for example, tuberculosis or measles. These organisms are present in smaller droplets expelled by an infected person and...
Physiological Barriers01:25

Physiological Barriers

Physiological barriers are semi-permeable cellular structures restricting drug diffusion into intracellular compartments and tissues. There are six types of physiological barriers: blood endothelial, cell membrane, blood-brain, blood-cerebrospinal fluid (CSF), blood-placenta, and blood-testis barriers.
The blood endothelial barrier is the most porous of these. It allows all small ionized, un-ionized, and lipophilic molecules to pass through the endothelial lining into the interstitial space...
Zones of Protection01:16

Zones of Protection

In power systems, the entire setup is divided into protective zones to isolate faults and protect the rest of the network. These zones include generators, transformers, buses, transmission lines, distribution lines, and motors. Each zone can be visualized as a separate room in a house, with each room protected by its own circuit breaker.
Protective zones are defined by closed dashed lines, containing one or more components. A key characteristic of these zones is the strategic placement of...
Overview Of Cell Separation And Isolation01:20

Overview Of Cell Separation And Isolation

Cell separation was first achieved in 1964 by S. H. Seal, who separated large tumor cells from the smaller blood cells using filtration. Two years later, Pohl and Hawk performed experiments on how cells respond differently to a nonuniform electric field based on the cell type. Such observations were the inception of cell separation methods, which allow isolating a single cell type from a heterogeneous sample.
Barriers to Effective Communication II01:21

Barriers to Effective Communication II

The barriers to effective communication also include cultural barriers, semantic barriers, gender barriers, and time constraints.
Cultural barriers:
Differences in values, beliefs, religion, knowledge, and tradition can significantly impact communication. Awareness of nonverbal cues is critical, especially when conversing with a patient from a different culture. What appears appropriate in one culture may be inappropriate in another.
Semantic barriers:
As a result of their tendency to use...
Barriers to Effective Communication I01:30

Barriers to Effective Communication I

A communication barrier is any distortion or interruption during a conversation, resulting in miscommunication of the message. A good communicator should know these barriers and continuously check for the listener's understanding by obtaining feedback.
Communication barriers include the following:
Physiological barriers: They are limitations caused by a person's health condition or disability, such as hearing loss, poor eyesight, illness, or unconsciousness. An example to overcome this barrier...