Entries by Dennis

Negative Pressure Room

What is a negative pressure room A negative pressure room, also known as a “negative pressure isolation room” is a controlled, critical area, which maintains a negative pressure differential to a non-controlled space. The need for such controlled spaces has increased dramatically in light of the COVID-19 pandemic. Most U.S. hospitals use negative-pressure airborne infection […]

Stop COVID-19 From Spreading – Isolation Room Safety

Isolation Room Basics Isolation rooms are controlled, critical environments in hospitals. When patients have communicable diseases like COVID-19, they are normally placed in one of these isolation rooms. Isolation rooms achieve their effectiveness in controlling contagious disease by keeping internal room pressures lower that areas outside of the room, thus keeping all of the ‘bad […]

Expectations of USP <797> vs cGMPs

ISO requirements for Compounding Sterile Pharmacies (CSP’s) Expectations of USP <797> Compounding Personnel USP <797> F identifies that compounding personnel represent the greatest threat to the safety and efficacy of a CSP, and as such, these personnel must be fully trained prior to preparing any type of CSP. Training should include live/electronic instructional sources (where […]

Airborne Infection Isolation Rooms (AIIRs) & COVID-19: Ensuring Patient Containment

Airborne Infection Isolation Rooms (AIIRs) All U.S. hospitals should be prepared for the possible arrival of patients with Coronavirus Disease 2019 (COVID-19). All hospitals should ensure their staff are trained, equipped and capable of practices needed to: Prevent the spread of respiratory diseases; including COVID-19 within the facility Promptly identify and isolate patients with possible […]

“Ball In The Wall” Not Effective For COVID-19 Control

Controlling COVID-19: Hospitals Very basic and antiquated devices such as the “Ball In The Wall” negative room pressure monitors are highly ineffective compared to the TV2 in preventing cross-contamination from infectious disease such as COVID-19 (Coronavirus).  Hospitals have a monumental challenge ahead in light of the world-wide outbreak of the contagious COVID-19, otherwise known as […]

Modular Cleanrooms

Cleanrooms are basically controlled spaces where particulate counts, temperature, relative humidity and pressure are controlled and monitored. While movies and the sci-fi genre may make these spaces seem very high-tech, they are actually quite basic in design and function. In fact, you can transform almost any existing space into a cleanroom, although the cost of […]

Clean Room Design & Build

test Industrial Applications Process Classification Aerospace ISO Class 5-7 Assembly of Touch Screen ISO Class 7 Composite Materials ISO Class 8 General Industrial ISO Class 8 Injection Molded Parts ISO Class 7-8 Optical ISO Class 5-7 Electronics Process Classification Semiconductor ISO Class 5 SMT Assembly ISO Class 7-8 Solar ISO Class 5-7 Wafer Board ISO […]

Seattle Children’s Hospital: Preventable Disaster?

In May 2019, Seattle Children’s Hospital faced an emergency situation where 14 surgical rooms were forced to cease operations, with over 3,000 families potentially affected by deadly Aspergillus mold exposure. The Seattle Children’s hospital was forced to move or reschedule over 1,000 surgeries. Unfortunately, one patient recently died in 2018 after developing an infection as […]

EU GMP Annex-1

Introduction Annex 1 of the EU GMP is a guideline and set of specific rules describing the European Union’s requirements for the manufacture of sterile medicinal products, including what we refer in the USA as “compounding pharmacies.” EU MP Annex 1 guidelines are applicable to all EU nation states in regards to pharmaceuticals bought, sold […]