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This study has compelled us to begin putting
“ stowaway sensors ” in every transportation route , so we can collect real-time temperature and humidity readings from inside a container . Over time this will produce a vast data pool of readings that illustrate the correlation between the environment , the vehicle , and the tray .”
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Active Monitoring
We proved to ourselves the value of active monitoring , specifically of temperature and humidity . While we can always pursue new techniques that make it “ easier to withstand the elements ,” we learned that the real-time monitoring is our most valuable tool , because it is the only strategy that allows us to intervene while there is still time to change a situation that is trending badly .
Active Control
Conditions on the open road are constantly changing . Shade can be replaced instantly with sunshine and heat , and doors opened frequently to the external environment . We proved to ourselves that it is important to standardize on a delivery vehicle which can actively manage temperature and humidity in a vehicle .
Temperature , Vibration and Shock
We confirmed that all things behave in ways that reflect the principles of physics , thermodynamics and heat transfer . Rigid containers do act as a buffer that reduces the rate at which the external environment affects the temperature of the actual instruments . Shock is reduced significantly using dampening materials such as neoprene rubber . And these are the variables we must focus on in the development of a transportation strategy for soiled and sterile instruments .
Next Steps
In a perfect world , this study would now be embraced as the spark for a new scientific study that involves much more testing with many more test subjects . A handful of sensors taking turns collecting readings from two cars , an SUV and a delivery van is hardly a large study . That said , it just isn ’ t feasible to create this kind of research undertaking , and it is for that reason that we will turn to future commercial operations for additional insights .
This study has compelled us to begin putting “ stowaway sensors ” in every transportation route , so we can collect real-time temperature and humidity readings from inside a container . Over time this will produce a vast data pool of readings that illustrate the correlation between the environment , the vehicle , and the tray . More to the point , this data takes us to a new level when it teaches us how to structure the right alerts during transit , about the need to make a change .
Cathy Castro , Chem Eng , MS , ASQ CQA , is a quality and chemical engineering professional with 24 years of progressive experience in the pharmaceutical , medical device , biotech , and healthcare fields to maintain QMS regulatory compliance with federal / state regulations and standards . In the last 10 years , Castro has supported the commissioning and establishment of a QMS for medical areas
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such as a stem cell processing center , and most recently , for an off-site sterile processing facility .
Tracy Raymond , BHA , MSM , CRCST , CIS , CER , CHL , has been in the healthcare industry for nearly 30 years . She started out as an SPD tech at a small community hospital where she quickly learned that sterile processing was her passion . After obtaining her bachelor ’ s degree she moved into a managerial role at a larger hospital where she helped to plan a new department at a new facility and assisted with the planning of the departmental move . Raymond then went on to obtain her master ’ s degree . While working as a leader in the SPD department she also taught sterile processing courses at a local community college for several years . She then traveled a bit as an interim SPD leader , assisting troubled departments across the nation . She is currently the manager of education and training for an off-site sterile processing facility .
Jen Barnickel , BHA , CRCST , CIS , CH , has been in the healthcare industry for almost 20 years . She discovered her passion for the surgical world while on a mission trip to northwest Haiti and upon returning home , promptly began school to become a surgical technician . After graduation , Barnickel helped set up and launch an ASC where she performed the combined role of surgical , endoscopy , inventory , and sterile processing technician . She then moved to a role at the neighboring hospital as a case cart specialist / OR liaison . After a few years in that role , she became the manager of sterile processing , earned her bachelor ’ s degree , and completed a full department renovation . She is currently the operations manager of an off-site sterile processing facility .
References :
Driving innovation : A transportation methodology to support the transition of orthopedic surgery from acute to ambulatory care . J Ortho Experience and Innovation . July 5 , 2021 .
Ammann C . Handling Temperature Excursions and the Role of Stability Data . Sept . 25 , 2013 .
USP 36 ( 1079 ) Good Storage and Distribution Practices for Drug Product .
ANSI / ASHRAE / ASHE Standard 170-2017 , Ventilation of Health Care Facilities – Addendum A . Good Storage and Distribution Practices for Pharmaceutical in European Union . J Pharm Sciences and Research . Vol . 11 ( 8 ).
USP < 659 > Packaging and Storage Requirements ( Temp excursions and MKT ).
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products . https :// database . ich . org / sites / default / files / Q1F _ Stability _ Guideline _ WHO _ 2018 . pdf
National Weather Service . https :// www . weather . gov / arx / why _ dewpoint _ vs _ humidity
Condensation , Humidity and Dew Point Temperature . https :// www . provia . com / images / img / pdf / condensation-flyer . pdf
Dewpoint table . https :// www . lamtec . com / technical-bulletins / dew-point-table /
Moisture meters . https :// www . grainger . com / know-how / equipment-information / kh-types-of-moisture-meters-qt-346
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Over time this will produce a vast data pool of readings that illustrate the correlation between the environment , the vehicle , and the tray . More to the point , this data takes us to a new level when it teaches us how to structure the right alerts during transit , about the need to make a change .” |