{"id":17072,"date":"2024-02-28T15:24:00","date_gmt":"2024-02-28T15:24:00","guid":{"rendered":"https:\/\/acin.nl\/rms\/?page_id=17072"},"modified":"2024-05-17T08:42:37","modified_gmt":"2024-05-17T08:42:37","slug":"pharmacies-drugstore-monitoring","status":"publish","type":"page","link":"https:\/\/acin.nl\/rms\/en\/pharmacies-drugstore-monitoring\/","title":{"rendered":"Pharmacies &#038; Drugstore Monitoring (Temperature)"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text]A pharmacy, chemist\u2019s or drugstore is a physical location that, amongst others, distributes medication for patients. The distribution is subject to pharmacy legislation and pharmacies fall under the Good Distribution Practice (GDP) quality guidelines that are developed by the regulatory authorities and are designed to cover the product quality over the complete life cycle of the product.<\/p>\n<p>GDP describes the minimum standards that must be met to ensure that the quality and integrity of medicines is maintained throughout the supply chain. GDP applies to sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of medicines. Here are some of the GDP guidelines\/regulations:<\/p>\n<ul>\n<li>WHO Annex 5: Good Distribution Practices for pharmaceutical products.<\/li>\n<li>The EU GDP guidelines are defined by the European Commission: Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.<\/li>\n<li>FDA 21 CFR Part 211 Current Good Manufacturing Proactive for Finished Pharmaceuticals.<\/li>\n<li>USP&lt;1079&gt; Good Storage and Distribution Practices for Drug Products.<\/li>\n<\/ul>\n<p>Typically, standalone temperature indicators or loggers are used and the monthly minimum and maximum temperature charts as well as daily temperature charts are done either by hand or by taking the logger to a PC to download the data.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion][vc_tta_section title=&#8221;Continuous monitoring system&#8221; tab_id=&#8221;1709132921116-927d011e-e81a&#8221;][vc_column_text]Continuous temperature monitoring is the perfect way to ensure that the environment where medicinal products are stored meets the product requirements and reduce human interaction. All reporting can be done at the push of a button and the pharmacy team can focus on their patients.<\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Area qualification&#8221; tab_id=&#8221;1709132921120-3ac61fe1-b189&#8243;][vc_column_text]In order to ensure that the temperature data loggers are located in the area that experience the extremes of fluctuations, an initial temperature mapping exercise should be carried out under representative conditions. Further to a risk assessment, the temperature mapping should be repeated on a regular basis.<br \/>\nThe storage and distribution temperatures defined by the U.S. Pharmacopeia (USP) are the following:<\/p>\n<ul>\n<li>Liquid Nitrogen (submerged): -196\u00b0C.<\/li>\n<li>Liquid Nitrogen (vapor phase): -150\u00b0C.<\/li>\n<li>Dry Ice: -80\u00b0C.<\/li>\n<li>Frozen: -25\u00b0C\u2026-10\u00b0C.<\/li>\n<li>Cold\/Refrigerated: 2\u20268\u00b0C.<\/li>\n<li>Cool: 8\u202615\u00b0C.<\/li>\n<li>Controlled Room Temperature (CRT): 20\u202625\u00b0C.<\/li>\n<\/ul>\n<p>The equipment used to monitor the environment where the medicinal products are stored should be calibrated at regular intervals, also defined by a risk assessment. The calibration should be traceable to a national or international standard.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;The Rotronic Monitoring System solution&#8221; tab_id=&#8221;1709133028558-a3d08c95-9f34&#8243;][vc_column_text]The Rotronic Monitoring System (RMS) is a GAMP\u00a95 category 4 software combined with category 1 hardware, helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, helping focus on patient safety, product quality and data integrity and compliant to EudraLex Annex 11 and FDA 21 CFR Part 11.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Choose a device&#8221; tab_id=&#8221;1709133066207-83afb87c-89c3&#8243;][vc_column_text]The USP 1118 Monitoring Devices \u2013 Time, temperature and humidity offers an overview of the measurement devices that can be used and explains the various technologies. Rotronic employs the following technologies for the wired or wireless electronic data loggers:<\/p>\n<p>As a regular calibration is required, the reminder function within RMS will help define and remind when a device requires a new calibration.<\/p>\n<p>Temperature sensors:<\/p>\n<ul>\n<li><a href=\"https:\/\/service.rotronic.com\/manual\/temperature-pt100.html\" target=\"_blank\" rel=\"noopener\">Resistance Temperature Detectors (RTD): Pt100 and Pt1000&#8217;s<\/a><\/li>\n<li><a href=\"https:\/\/service.rotronic.com\/manual\/sensors4.html\" target=\"_blank\" rel=\"noopener\">Thermistors: NTC&#8217;s<\/a><\/li>\n<\/ul>\n<p>Relative humidity sensors:<\/p>\n<ul>\n<li><a href=\"http:\/\/www.michell.com\/uk\/products\/optidew_401_501.htm\" target=\"_blank\" rel=\"noopener\">Dew Point hygrometer<\/a><\/li>\n<li><a href=\"https:\/\/service.rotronic.com\/manual\/hcd-sx.html\" target=\"_blank\" rel=\"noopener\">Capacitive Thin-film hygrometer<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Notifications&#8221; tab_id=&#8221;1709133172347-81f9d0b9-57a4&#8243;][vc_column_text]RMS allows the user to configure each measuring points with a warning (pre-alarm) and an alarm. Both the warning and the alarm can be configured with a delay (for example for differential pressure) as well as a hysteresis. Notification repetitions can be setup to ensure that critical events are not forgotten, warnings and alarms can be sent via E-Mail, SMS and telephone call.<\/p>\n<p>RMS will allow for specific users to adapt the various levels to ensure that optimal levels are maintained: all changes are documented within the audit trail, stating the user who made the changes, the time stamp and the values before and after the change.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Deviation Monitoring&#8221; tab_id=&#8221;1709133203384-a9904d23-ee2b&#8221;][vc_column_text]<\/p>\n<div id=\"accordion_body_2\" class=\"accordion_body\">\n<div class=\"panel-body\">\n<div class=\"row with-gutter clearfix\">\n<div class=\"col-sx-12 col-sm-9 col-md-9 col-lg-9\">\n<p>All level excursions are easily and quickly visible within RMS. Each event can be acknowledged and commented so that in case of an audit all relevant information is available. RMS has been built up on a digital level, so any hardware changes will also be visible within the RMS audit trail.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Calculations in RMS&#8221; tab_id=&#8221;1709133232590-cc70e265-e676&#8243;][vc_column_text]RMS offers a range of additional calculations to help the users get the most out of their system.<\/p>\n<p>RMS offers the possibility to calculate the Mean Kinetic Temperature.<\/p>\n<p>The mean kinetic temperature is the total influence of temperature on an object or product over a certain period of time.<\/p>\n<p>Extract from the ICH Topic Q 1 A (R2): Stability Testing of new Drug Substances and Products:<\/p>\n<p>Mean kinetic temperature: a single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation.<\/p>\n<p>When establishing the mean kinetic temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927-929, 1971) can be used.<\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-17073\" src=\"https:\/\/acin.nl\/rms\/wp-content\/uploads\/2024\/02\/mean_kinetic_temperature-300x93.jpg\" alt=\"\" width=\"300\" height=\"93\" srcset=\"https:\/\/acin.nl\/rms\/wp-content\/uploads\/2024\/02\/mean_kinetic_temperature-300x93.jpg 300w, https:\/\/acin.nl\/rms\/wp-content\/uploads\/2024\/02\/mean_kinetic_temperature.jpg 396w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>TK is the mean kinetic temperature in kelvin.<br \/>\n\u0394H is the activation energy (in kJ mol-1).<br \/>\nR is the gas constant (in J mol-1 K-1).<br \/>\nT1 to TN are the temperature at each of the sample points in kelvin.<br \/>\nt1 to tn are the time intervals at each of the sample points.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Calibration Management&#8221; tab_id=&#8221;1709133380990-cb4849a5-06cb&#8221;][vc_column_text]RMS offers a calibration management tool. On one side, all devices can be calibrated within RMS, offering a complete traceability to a national or international measurement standard. Calibration reports can also be generated and documented within RMS.<\/p>\n<p>As a regular calibration is required, the reminder function within RMS will help define and remind when a device requires a new calibration.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]A pharmacy, chemist\u2019s or drugstore is a physical location that, amongst others, distributes medication for patients. The distribution is subject to pharmacy legislation and pharmacies<a class=\"moretag\" href=\"https:\/\/acin.nl\/rms\/en\/pharmacies-drugstore-monitoring\/\">&#8230;<\/a><\/p>\n","protected":false},"author":42,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"_links":{"self":[{"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/pages\/17072"}],"collection":[{"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/comments?post=17072"}],"version-history":[{"count":2,"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/pages\/17072\/revisions"}],"predecessor-version":[{"id":17076,"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/pages\/17072\/revisions\/17076"}],"wp:attachment":[{"href":"https:\/\/acin.nl\/rms\/en\/wp-json\/wp\/v2\/media?parent=17072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}