Các sản phẩm nhạy cảm với nhiệt độ như hóa chất, thịt, thực vật, thuốc và vắc-xin yêu cầu phải kiểm soát nhiệt độ từ khâu sản xuất đến tiêu dùng và mọi bước trung gian.
Tính nhất quán về nhiệt độ đảm bảo chất lượng của các sản phẩm này khi chúng di chuyển qua các chuỗi cung ứng tương ứng. Tuy nhiên, đảm bảo tính nhất quán nhiệt độ là một thách thức.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, thời gian. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Các sản phẩm nhạy cảm với nhiệt độ như hóa chất, thịt, thực vật, thuốc và vắc-xin yêu cầu phải kiểm soát nhiệt độ từ khâu sản xuất đến tiêu dùng và mọi bước trung gian.
Tính nhất quán về nhiệt độ đảm bảo chất lượng của các sản phẩm này khi chúng di chuyển qua các chuỗi cung ứng tương ứng. Tuy nhiên, đảm bảo tính nhất quán nhiệt độ là một thách thức.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, thời gian. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Pharma IQ’s Cold Chain & Temperature Management Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain. All new discussions will include: review of Health Canada’s revised <0069>, Canadian importation strategies, specialty logistics, stability data and risk mitigation.
Thực phẩm dễ hỏng ngay cả khi chúng được tối ưu hóa trong việc chế biến và đóng gói. Chúng cần được phân phối và lưu trữ một cách thích hợp để đảm bảo chất lượng và thời hạn sử dụng của chúng. Các mặt hàng dễ hỏng như sữa, rau, trái cây, hải sản, thịt, đồ đông lạnh và các sản phẩm dược phẩm như thuốc, vắc-xin, thuốc tiêm, v.v. Những sản phẩm này rất nhạy cảm với nhiệt độ và hạn sử dụng của chúng bị ảnh hưởng nếu không được bảo quản phù hợp. Để đảm bảo điều đó, cần có các kho chuỗi lạnh hiệu quả - nơi có thể quản lý sản phẩm, đồng thời giảm hao hụt.
Improving Processes for Temperature Traceability from Packaging to PatientPAREXEL International
Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional temperature monitoring methods, innovative methods and how to apply the best approach to individual studies.
How to Validate Temperatures Within the Supply ChainMichel Comtois
Michel Comtois, President of Micom Laboratories made this presentation to the Pharmaceutical and Personal Care Logistics Association.
The theme of the presentation: Documenting through testing and monitoring that we are in control of our logistics process from a temperature standpoint.
Recipe for successful Supply Chain Risk ManagementHeiko Schwarz
This white paper serves as support for everyone involved in implementing supply chain risk management (SCRM). These guidelines are intended to provide companies with a checklist containing all the ingredients that are important for setting up professional, successful supply chain risk management. In this way, time-consuming delays and costly errors can be avoided. The individual chapters contain detailed descriptions on the following ingredients for a comprehensive supply chain risk management process, and how to integrate them in an organization:
- Definition of the scope
- Definition of risks to be monitored ("Risk Inventory")
- Supply chain transparency
- Risk identification
- Risk assessment
- Action plan management for minimizing risks
- Integration into further procurement processes
As the approach described in this white paper is a generic one, specifics must be adapted to the relevant sector and company size in order to adapt the generic concept accordingly . You can find a detailed description of the benefits and the return on investment of supply chain risk management in the "ROI of Supply Chain Risk Management" study .
As is the case with any dish: Adjust the ingredients according to your personal (company-specific) liking!
Tiêu chuẩn GMP WHO cho nghiên cứu quản lý theo thời gian (hold-time study). Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
Components of a Successful Packaging Shelf-Life StudyNAMSA
A key design attribute of a terminally sterilized medical device is for the device to maintain sterility throughout the labeled shelf-life. This presentation discusses a few of the elements that are necessary for a successful packaging shelf-life.
A quantitative risk assessment approach in an integrated cold chain system en...eSAT Publishing House
IJRET : International Journal of Research in Engineering and Technology is an international peer reviewed, online journal published by eSAT Publishing House for the enhancement of research in various disciplines of Engineering and Technology. The aim and scope of the journal is to provide an academic medium and an important reference for the advancement and dissemination of research results that support high-level learning, teaching and research in the fields of Engineering and Technology. We bring together Scientists, Academician, Field Engineers, Scholars and Students of related fields of Engineering and Technology
Presentation from IFT Annual Meeting in 2008 by Dr. Claire Sand titled: Research Developments and Needs in Sustainable Packaging Metrics.
With 30 years of experience across the food science and packaging spectrum, Dr Claire Sand through her company, Packaging Technology & Research, offers clients solutions using Strategy, Technology, Consulting and coaching.
Want to know more about items reviewed in this presentation? Reach out to Dr Sand on Linked In - https://www.linkedin.com/in/clairekoelschsand
Want to keep learning? View more presentations at http://www.packagingtechnologyandresearch.com/thought-leadership.html
Dr. Claire Sand | Owner, Packaging Technology & Research, LLC; Adjunct Professor, Michigan State University; Columnist for Food Technology Magazine
http://www.packagingtechnologyandresearch.com/
ACHIEVING ENERGY EFFICIENCIES IN COLD STORAGESJack Watson
Energy is the next most significant cost element in any cold storage after Manpower. Organizations globally are under pressure to reduce costs and be energy effi¬cient, while not compromising on service quality. This paper discusses the challenges in energy management for cold storages suggesting ways to collect and analyze energy and to arrive at energy saving strategies that when applied would help in cost, performance and energy efficiencies.
Achieving Energy Efficiencies in Cold Storagesaayamkhatri
Energy is the next most significant cost element in any cold storage after Manpower. Organizations globally are under pressure to reduce costs and be energy effi¬cient, while not compromising on service quality. This paper discusses the challenges in energy management for cold storages suggesting ways to collect and analyze energy and to arrive at energy saving strategies that when applied would help in cost, performance and energy efficiencies.
Reliability, quality and a competitive price are table stakes in
the business of maintaining and repairing industrial facilities
and equipment, commonly known as Maintenance, Repair
and Operations (MRO). Given the nature of MRO, urgency can
often catapult to the top of the list of requirements. Sellers
who cannot consistently come through will almost certainly
be dropped from future consideration.
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Similar to Optimizing Packaging for Temperature-Sensitive Shipments
Pharma IQ’s Cold Chain & Temperature Management Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain. All new discussions will include: review of Health Canada’s revised <0069>, Canadian importation strategies, specialty logistics, stability data and risk mitigation.
Thực phẩm dễ hỏng ngay cả khi chúng được tối ưu hóa trong việc chế biến và đóng gói. Chúng cần được phân phối và lưu trữ một cách thích hợp để đảm bảo chất lượng và thời hạn sử dụng của chúng. Các mặt hàng dễ hỏng như sữa, rau, trái cây, hải sản, thịt, đồ đông lạnh và các sản phẩm dược phẩm như thuốc, vắc-xin, thuốc tiêm, v.v. Những sản phẩm này rất nhạy cảm với nhiệt độ và hạn sử dụng của chúng bị ảnh hưởng nếu không được bảo quản phù hợp. Để đảm bảo điều đó, cần có các kho chuỗi lạnh hiệu quả - nơi có thể quản lý sản phẩm, đồng thời giảm hao hụt.
Improving Processes for Temperature Traceability from Packaging to PatientPAREXEL International
Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional temperature monitoring methods, innovative methods and how to apply the best approach to individual studies.
How to Validate Temperatures Within the Supply ChainMichel Comtois
Michel Comtois, President of Micom Laboratories made this presentation to the Pharmaceutical and Personal Care Logistics Association.
The theme of the presentation: Documenting through testing and monitoring that we are in control of our logistics process from a temperature standpoint.
Recipe for successful Supply Chain Risk ManagementHeiko Schwarz
This white paper serves as support for everyone involved in implementing supply chain risk management (SCRM). These guidelines are intended to provide companies with a checklist containing all the ingredients that are important for setting up professional, successful supply chain risk management. In this way, time-consuming delays and costly errors can be avoided. The individual chapters contain detailed descriptions on the following ingredients for a comprehensive supply chain risk management process, and how to integrate them in an organization:
- Definition of the scope
- Definition of risks to be monitored ("Risk Inventory")
- Supply chain transparency
- Risk identification
- Risk assessment
- Action plan management for minimizing risks
- Integration into further procurement processes
As the approach described in this white paper is a generic one, specifics must be adapted to the relevant sector and company size in order to adapt the generic concept accordingly . You can find a detailed description of the benefits and the return on investment of supply chain risk management in the "ROI of Supply Chain Risk Management" study .
As is the case with any dish: Adjust the ingredients according to your personal (company-specific) liking!
Tiêu chuẩn GMP WHO cho nghiên cứu quản lý theo thời gian (hold-time study). Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
Components of a Successful Packaging Shelf-Life StudyNAMSA
A key design attribute of a terminally sterilized medical device is for the device to maintain sterility throughout the labeled shelf-life. This presentation discusses a few of the elements that are necessary for a successful packaging shelf-life.
A quantitative risk assessment approach in an integrated cold chain system en...eSAT Publishing House
IJRET : International Journal of Research in Engineering and Technology is an international peer reviewed, online journal published by eSAT Publishing House for the enhancement of research in various disciplines of Engineering and Technology. The aim and scope of the journal is to provide an academic medium and an important reference for the advancement and dissemination of research results that support high-level learning, teaching and research in the fields of Engineering and Technology. We bring together Scientists, Academician, Field Engineers, Scholars and Students of related fields of Engineering and Technology
Presentation from IFT Annual Meeting in 2008 by Dr. Claire Sand titled: Research Developments and Needs in Sustainable Packaging Metrics.
With 30 years of experience across the food science and packaging spectrum, Dr Claire Sand through her company, Packaging Technology & Research, offers clients solutions using Strategy, Technology, Consulting and coaching.
Want to know more about items reviewed in this presentation? Reach out to Dr Sand on Linked In - https://www.linkedin.com/in/clairekoelschsand
Want to keep learning? View more presentations at http://www.packagingtechnologyandresearch.com/thought-leadership.html
Dr. Claire Sand | Owner, Packaging Technology & Research, LLC; Adjunct Professor, Michigan State University; Columnist for Food Technology Magazine
http://www.packagingtechnologyandresearch.com/
ACHIEVING ENERGY EFFICIENCIES IN COLD STORAGESJack Watson
Energy is the next most significant cost element in any cold storage after Manpower. Organizations globally are under pressure to reduce costs and be energy effi¬cient, while not compromising on service quality. This paper discusses the challenges in energy management for cold storages suggesting ways to collect and analyze energy and to arrive at energy saving strategies that when applied would help in cost, performance and energy efficiencies.
Achieving Energy Efficiencies in Cold Storagesaayamkhatri
Energy is the next most significant cost element in any cold storage after Manpower. Organizations globally are under pressure to reduce costs and be energy effi¬cient, while not compromising on service quality. This paper discusses the challenges in energy management for cold storages suggesting ways to collect and analyze energy and to arrive at energy saving strategies that when applied would help in cost, performance and energy efficiencies.
Similar to Optimizing Packaging for Temperature-Sensitive Shipments (20)
Reliability, quality and a competitive price are table stakes in
the business of maintaining and repairing industrial facilities
and equipment, commonly known as Maintenance, Repair
and Operations (MRO). Given the nature of MRO, urgency can
often catapult to the top of the list of requirements. Sellers
who cannot consistently come through will almost certainly
be dropped from future consideration.
How to Add Agility and Customer Focus to the Healthcare Supply ChainUPS Longitudes
The global pharmaceutical and healthcare industry has
experienced a number of severe shocks to the system in
recent decades. What was once a sector where profits flowed
from ‘blockbuster’ drugs and a customer base willing to
pay premium prices has transformed into a quite different
world as a consequence of competition from generics along
with reduced budgets available to healthcare providers.
Compounding these problems are increasing regulatory
constraints and more challenging logistics requirements as
bio-pharmaceuticals and related products increase the need
for stricter control of temperature and shelf-life as they move
through the supply chain.
As a result there is now a significantly greater focus across
the sector on supply chain management. Previously, when
margins were higher and logistics costs were a relatively
small proportion of total costs, supply chain issues tended
to take a back seat. Now things have changed. Recent
research by UPS® has highlighted that many companies are
finding it difficult to develop supply chain capabilities that
can simultaneously take out costs whilst ensuring regulatory
compliance, track and trace, product security and stricter
temperature and shelf-life control.
Because of these pressures, a new approach to the design
and management of supply/demand networks in the industry
becomes imperative. In today’s marketplace, there is a need
for supply chains that are cost-effective, efficient and agile.
Companies operating in every industrial sector and in
every market around the world have been confronted in
recent years with significant challenges. These challenges
have come from numerous sources – economic recession,
demographic changes, geo-political upheavals to name but
a few. The healthcare and pharmaceutical industry has been
no exception and has been impacted by major changes in the
competitive and market environment.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
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According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Artificial Intelligence to Optimize Cardiovascular Therapy
Optimizing Packaging for Temperature-Sensitive Shipments
1. Optimizing Packaging
for Temperature-Sensitive
Shipments
Using the Risk-Controlled Ambient Thermal
Profile (RCATP) Methodology for Improving
Tertiary Package Design
Susan Li
Manager
UPS Temperature True® Packaging
2018 . UPS and Sensitech Inc . All rights reserved .
David E. Magargee
Global Programs Manager
Sensitech® Inc .
2. Table of
Contents
01
Introduction
02
The Role of Tertiary Packaging
in Protecting Temperature-
Sensitive Products
Why the right packaging is important. . . 04
How proper packaging can help. . . . . . . 04
Data analysis is key . . . . . . . . . . . . . . . . 05
03
RCATP: A Comprehensive,
Proven Methodology
Why choose RCATP over
other approaches. . . . . . . . . . . . . . . . . . 07
04
An In-Depth Look at the
RCATP Methodology
Ideal temperature. . . . . . . . . . . . . . . . . . 08
Heat and negative heat values. . . . . . . . 08
Trip length (or time in transit). . . . . . . . . . 10
Determining acceptable levels of risk . . . 11
05
Real-Life Data:
The UPS Shipping Network
How the studies were conducted. . . . . . 12
06
The Results:
Four RCATPs with UPS Data
RCATPs using the 99th
percentile. . . . . . 15
RCATPs using the 95th
percentile. . . . . . 15
07
Conclusion: RCATPs are critical
to reducing risk
UPS | SENSITECH
2
3. Introduction
For companies responsible for the transport of temperature-sensitive
products, it is important to understand how the temperatures of the in-transit
environment can affect the products being shipped. This knowledge can help
direct the design of tertiary packaging that can protect products from adverse
temperature variances, which in turn can reduce supply chain costs and
lessen overall risk.
To provide insights into this, Sensitech® Inc. and UPS® joined together to
author this paper on how to use the Sensitech Risk-Controlled Ambient
Thermal Profile (RCATP) methodology to improve the effectiveness of
tertiary packaging.
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
3
4. The Role of Tertiary Packaging in Protecting
Temperature-Sensitive Products
For temperature-sensitive product manufacturers and shippers, product loss or damage—and the
associated risks—while the goods move through the supply chain is a major concern. UPS, a global
leader in logistics, shared insights on this in its Eighth UPS Pain in the Chain survey of healthcare
logistics executives.
Why the right packaging is important
How proper packaging can help
Thermal tertiary packaging is a key component in protecting the quality of temperature-sensitive
products in the supply chain. However, this kind of packaging is often either over- or under-engineered,
which can increase supply chain costs and decrease product efficacy.
63% of the executives surveyed
believe that a core supply chain
issue is product damage
and spoilage.
47% say that increasing regulatory
requirements involving cold-chain
or temperature-sensitive packaging
are driving up costs.
48% stated that their success with
product damage and spoilage
is due to the use of thermal
packaging and containers.
When products or packaging are compromised,
there are costly ramifications, including those
associated with the manufacturing of replacement
products and packaging, pack-out assembly and
transportation. In addition, there could be loss of
retail revenue, along with other related expenses
such as quarantine, testing, disposal and brand
equity damage. The worst case scenario is
compromised product reaching the consumer.
Package designers can then use this data, along
with other design considerations, to develop
packaging that has the greatest potential to
maintain product temperatures when exposed to
ambient temperatures in the real world.
Depending on the lane, time of year, level of
shipping service selected and other factors,
there can be an extremely wide range of ambient
temperatures. The temperatures that packages
may be exposed to while being shipped could
be higher than 70°C and lower than -20°C.
Adverse heat gain or loss by exposure to ambient
temperature over time during shipping can affect
the ability of a temperature-sensitive product or its
packaging to withstand temperatures that exceed
a defined ideal range. Exposure to temperatures
outside of a product’s ideal range can impact
product efficacy.
Thermal tertiary packaging, which protects
goods during shipping with materials such as
corrugated boxes, insulating materials and
phase-change materials, can effectively reduce
many of the risks noted above.
To design optimal tertiary packaging, it’s important
to determine what an ideal and acceptable
shipping time and temperature range is for
the specific tolerances of a particular product.
63% 47% 48%
UPS | SENSITECH
4
5. Data analysis is key
A UPS report, How to Select Tertiary Packaging, notes, “A product may be shipped outside of its label
storage conditions only when stability data or scientific/technical justification exists to demonstrate
that quality will not be adversely impacted.” The report also mentions that this is especially important
for products that are sensitive to conditions outside of their storage requirements. For these kinds of
products, it’s key to identify the risks and take steps to alleviate them.
This is where Ambient Temperature Profiles (ATPs) are helpful, as they provide a statistical analysis
of time-temperature data for use during the phase of packaging design where thermal packages are
tested in a temperature-controlled chamber.
Collecting an appropriate dataset of time and temperature data and analyzing the distribution of
expected temperatures in a particular shipping network is the best way to predict and quantify the
thermal risk in any supply chain network.
This information is vital for packaging designers, as ATPs provides data they can use as parameters for
creating packaging prototypes that can maintain specified temperature ranges for a range of given times.
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
5
7. RCATP: A Comprehensive,
Proven Methodology
There are a variety of ATP methodologies available on the market from various organizations. One such
approach is the Risk-Controlled Ambient Thermal Profile (RCATP) Methodology developed by Sensitech®
Inc., a world leader in supply chain visibility.
Based upon Newton’s law of cooling, the RCATP approach uses a risk-weighted evaluation of variable
temperatures as a means of quantifying the risk of a temperature excursion. It provides a more
comprehensive analysis of time and temperature data from a shipping network than most ATPs—
and here’s why.
Typically, ATP data is collected for creating ‘hot’ and ‘cold’ season profiles to minimize the cost of
packaging and to identify the appropriate time to transition to packaging for a hotter or colder season
ahead. However, most ATP methodologies don’t show what happens on a cold day in a hot season,
or a hot day in a cold season, as they don’t measure the full range of temperatures during a season.
To provide more comprehensive insight, the RCATP methodology uses two profiles, or a profile set.
The two profiles in a set contain one profile representing the upper or hottest expected trip, and a
lower profile representing the coolest expected trip. With this comprehensive data, package testing
can be on the full range of temperatures—both highs and lows—that can occur within one season
or across multiple seasons. This methodology gives packaging designers a higher level of confidence
that the chamber-tested packaging will withstand all ambient temperatures within a given supply chain.
Why choose RCATP over other approaches
The two-profile approach of an RCATP
analysis provides significant benefits over other
methodologies, including these:
• As a consultative process, the RCATP
methodology considers a wider array of
variables than other approaches. An RCATP
analysis can potentially include data on
product stability, product cost, process cost,
distribution options and service levels, as well
as packaging and design costs.
• With the RCATP methodology, companies
can assess their product failure rates and
excess logistics costs while minimizing the
total cost of distribution. For example, an
RCATP analysis allows companies to measure
the cost of maintaining quality by providing
protection via thermal packaging and specialty
logistics services. Decision-makers can
compare the cost of such protection against
the risk and projected costs associated with
product quarantine or loss due to the negative
effects of thermal exposure.
• This approach can also help companies define
their supply chain requirements to determine
what kinds of investments are needed to
maintain product quality, consumer safety and
regulatory compliance. Companies can identify
and weigh various trade-offs, and intelligently
define the level of variability or risk they are
willing to take. For instance, companies can
determine what an acceptable level of risk is
for a specific distribution network, and utilize
an iterative package design process to help
optimize distribution costs against an informed
risk tolerance. This approach can also inform
a variety of choices in designing other factors
in a distribution system, such as the selection
of lane clusters, transportation mode, and
shipping service levels.
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8. 1. Ideal temperature
The RCATP methodology relies on creating an arbitrary temperature that represents the optimum
temperature at which a product should be stored to maintain efficacy . For many life science products,
a “label claim” that meets regulatory compliance is typically 2-8°C . The optimum or ideal temperature
for this range is typically agreed to be 5°C, as it represents the mean of the two limits . Therefore,
RCATPs for life sciences products often use 5°C as an ideal temperature .
2. Heat and negative heat values
A defining feature of the RCATP methodology is the ability to compare various shipments, or trips, to
one another and to average ATPs . For these trip comparisons, the RCATP methodology utilizes two
statistically derived metrics called “heat value” and “negative heat value .” These calculations quantify
the amount of heat associated with a specific trip or profile, or any time-temperature series .
The heat value and negative heat value measure the difference between a time and temperature series
and the selected ideal temperature (see Figure 1) . Typically these metrics would be calculated on a
cohesive data set of a single shipping lane or grouping of lanes .
Note: This content of the paper covers the methodology of an RCATP with the assumption that
data for this analysis has already been captured based on specific design and execution parameters
individually tailored to a company’s specific objectives. The process of how that data is captured is
outside the scope of this paper.
-5
0
5
10
15
20
25
30
35
Ideal
Time (hours)
Temperature(°C)
5 10 15 20 25
Ambient Temperature
-5
0
5
10
15
20
25
30
35
Time (hours)
Temperature(°C)
5 10 15 20 25
Ideal
Ambient Temperature
Figure 1: The gray area in the left graph shows a trip’s heat value, or the amount of time above the ideal
range. The graph on the right shows the negative heat value, or the time below the ideal temperature,
for the same trip.
An In-Depth Look at the RCATP Methodology
The RCATP methodology is based upon three primary concepts:
1
2
UPS | SENSITECH
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9. In Figure 2 below, the positive and negative heat values from five different shipments are depicted .
The most extreme trips from the dataset, using heat and negative heat, have been highlighted in red
and blue respectively, in the right section of Figure 2 . For instance, the metrics show that Trip 5 had
a more extreme negative heat value than Trip 1, while Trip 4 had a more extreme heat value than any
other trip . This set of heat values becomes critical when deciding the risk level of each RCATP .
Example Data Set Multi-Graph
5 10 15 20 25 30 35 40 45 50
-5
0
5
10
15
20
25
30
35
Trip 1
Trip 2
Trip 3
Trip 4
Trip 5
Ideal
Hours
°C
Figure 2: Each of the time-temperature records for five separate trips has a heat and negative heat
value, which can ultimately inform the high and low profiles in an RCATP profile set.
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
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10. 3. Trip length (or time in transit)
When undertaking an RCATP analysis, companies
must decide length of the thermal profile . Typically,
for the shipment of small packages, this would be
anywhere from 24 to 120 hours, depending on
considerations such as shipping method, length
of routes or standard operating procedures .
Some companies choose to use the length of live
shipments and use the period of the actual time
period from pickup to delivery for analysis . In all
cases, delivery delays should be considered while
designing profiles and packaging, and appropriate
contingency plans should be defined .
This step in the RCATP groups the temperature
data points from the analysis in Figure 2 into
hourly “buckets .” The first hour of temperature
data for all of the above five trips are grouped
into Bucket 1, with the second hourly records
placed into Bucket 2, and so forth . Each bucket
is then displayed as a distribution, with a mark
(teal dot) for each temperature data point .
3
Figure 3: Grouping data into hourly buckets can
help companies increase or decrease risk.
0
5
-5
-10
10
15
20
25
30
35
0 5 10 15 20 25
Hour
°C
UPS | SENSITECH
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11. With the information from Figure 3, companies
can then establish a level of risk that they are
willing to take by assigning an independent
percentile for each profile . Within the distribution
points, companies can assign a high and low
percentile that is based on factors such as risk
aversion and product stability that meet their
unique product requirements .
This example uses 90% to illustrate how the
percentiles relate to each profile . In Figure 4, the
first two hours are connected where 90% of the
data falls below the line .
Hour 1 & 2 Bucket
0
5
10
15
20
25
30
0 1 2 3
Hour
°C
Figure 4: Connecting the first two hours of data
This concept is continued through the entire
dataset in Figure 5 . Building a lower profile is
the same concept, but uses lower percentiles,
typically between 0% and 20% . Increasing or
decreasing the percentiles will result in more or
less extreme profiles .
Determining acceptable levels of risk
Data Grouped by Hour
0
5
-5
-10
10
15
20
25
30
35
0 5 10 15 20 25
Hour
°C
Figure 5: Construction of the upper profile
Using these percentiles, companies can then see
what percentage of shipments they might expect
to be at risk of thermal failure by encountering
more extreme heat and negative heat values than
the package was designed to withstand . This is a
critical component of making risk-based decisions
not only for package design, but supply chain
options as well .
When the percentiles are calculated across the
duration of the trip, the result is the two time-
temperature profiles . A final profile set with both
profiles is seen in Figure 6 .
Upper and Lower Temperature Profiles
-10
-5
0
5
10
15
20
25
30
35
Ideal
Time (hours)
Temperature(°C)
5 10 15 20 25
Figure 6: Upper and lower profiles in an RCATP
profile set
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
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12. Real-Life Data: The UPS Shipping Network
How the studies were conducted
To provide its customers with a better
understanding of the benefits of an RCATP
model, UPS used Sensitech’s methodology for
analyzing its own shipping data. In doing so,
UPS hopes to provide customers with insights
that can help them optimize the engineering
and manufacturing of packaging for small,
temperature-sensitive shipments traveling
through its network.
Since 2011, UPS used thousands of Sensitech temperature-sensing monitors to collect ambient
temperatures across its shipping lanes in the United States. The goal was to capture in-transit ambient
temperature data between UPS origin sites and destination locations in the United States.
To capture temperatures representative of different geographical locations, the United States was
divided into four zones. [Define the zones, provide a map to show the zones]. Within each zone,
multiple receiving sites were selected and used to create an appropriate geographical spread.
Zone Map
Zone 4
Zone 3
Zone 1
Zone 2
With the sample data here, UPS customers
can gain valuable insights that will help them
determine how to use an RCATP to mitigate the
risks presented by heat and cold experienced
during transport. By more accurately aligning
their packaging with the thermal challenges of the
network, UPS customers have an opportunity for
realizing significant cost savings on packaging,
shipping and reducing rejected shipments.
UPS | SENSITECH
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13. Four seasonal studies were conducted over a period of two years with the goal to capture extreme
seasonal variations of shipments while in transit . The studies included data from:
1. Summer (July and August) of 2011
2. Winter (January and February) of 2012
3. Winter (January and February) of 2013
4. Summer (July and August) of 2013
The information collected during these four studies resulted in:
Over 270,000 data points
. . .from almost 1 .5 million UPS tracked package miles
…on shipments from 12 points of origin and over 200 destinations
…for both UPS Next Day Air® and UPS Second Day Air® small package services .
How the data was collected:
• Each of the individual shipments was equipped with a single Sensitech TempTale®4 temperature
monitor placed inside a ventilated, corrugated box without insulation or refrigerants to record actual
environment temperature in-transit . Each monitor was programmed to record temperatures every
10 minutes during transit .
• Each monitor was turned on when the shipment was prepared for transportation in one of 12 UPS
warehouses/facilities . All shipments were sent to locations of the UPS Store nationwide to simulate
the routing of a typical business address . UPS Stores staff would turn off the monitor upon receiving
the shipments . Data from all monitors was downloaded and consolidated .
Destination Locations – UPS Stores
Zone 4
Zone 3
Zone 1
Zone 2
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14. • Sensitech and UPS worked collaboratively to define procedures, responsibilities, equipment,
instructions, purpose and required analysis prior to initiating the program.
• Regarding data gathering, Sensitech trained UPS personnel on the proper data collection
processes to ensure program compliance.
• All data was stored in Sensitech ColdStream® Cold Chain Manager software, which is a 21
CFR Part 11-compatible data-storage environment created specifically to manage temperature
information. Data held within ColdStream cannot be changed, overwritten, or deleted, and is
password protected. All changes to the database are tracked, date-stamped and stored along
with the user identity that performs each action.
• The RCATP methodology developed by Sensitech relies on creating an optimum temperature at
which a product should be stored based on stability data. Because the goal of this RCATP project
is to protect refrigerated product for UPS customers, a 5°C ideal temperature was selected.
• At the end of each study, Sensitech compiled formal reports from the findings, and key findings are
included here in this report.
NOTE: Although the seasonal studies were similar in terms of data collection, there were some notable
differences. For example, the Summer 2011 and Winter 2012 studies had three origin facilities per
zone, and the Winter and Summer 2013 studies had two origin facilities. Each of these origin facilities
shipped test packages to locations in all four geographical zones.
UPS | SENSITECH
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15. The Results: Four RCATPs with UPS Data
To help its customers establish their risk
tolerance, the UPS profiles used the 99th
percentile of the set of heat values and negative
heat values for one summer and winter profile,
and the 95th percentile for another summer and
winter profile.
With this understanding, UPS customers can
select from between a more or slightly less
robust package design, depending on product
temperature requirements.
The following figures display the four UPS profile
sets, one for each study.
• The orange lines in each represent the upper
temperature profile (99% or 95%) and the
green line represents the lower temperature
profile (1% or 5%) in each.
• The horizontal gray line represents the ideal
temperature (5°C) established for this study.
• The vertical brown bars represent the
maximum and minimum temperatures
recorded in each hour group.
RCATPs using the 95th
percentile:
These four profiles show the wide variations that can occur from season to season and from trip
to trip, and the level of risk that could be assigned to an RCATP analysis.
Figure 9: Summer 95th percentile (2013) Figure 10: Winter 95th percentile (2013)
RCATPs using the 99th
percentile:
Figure 7: Summer 99th percentile (2011) Figure 8: Winter 99th percentile (2012)
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
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17. Conclusion
RCATPs are critical to reducing risk
The daily highs and lows of ambient
temperatures will continue to be affected by
the conditions of transportation—and they will
always vary. In truth, there is no way surefire way
to forecast the conditions that each shipment
will encounter. But a dataset from individual
actual shipments can be used to generate an
ambient profile that is of demonstrable value to
the design of tertiary packaging.
The utilization of ambient temperature profiles like
the Sensitech RCATP analysis is an effective—
and, indeed, essential—way to optimize tertiary
packaging solutions for temperature-sensitive
shipments. Given the breadth of parameters
and the wide range of variables involved, it is
wise to continually collect real-world data to
help determine the amount of risk in shipping
temperature-sensitive products and how to
reduce it. Repeated experimentation in actual
shipping lanes can help ensure the most accurate
guidance for packaging designs.
The speed of transport chosen needs to be
taken into consideration as well. While a faster
route generally results in a less extreme ambient
temperature profile, that generalization doesn’t
apply when a shipment unexpectedly ends up
spending several hours in the hot Arizona sun,
or the freezing cold of Alaska.
Taking into consideration the wide array of
possible data in an RCATP analysis gives
companies with the opportunity to optimize a
transportation solution and minimize damage
and spoilage, maximize efficiency, reduce risk
and most importantly, keep consumers safe.
OPTIMIZING PACKAGING FOR TEMPERATURE-SENSITIVE SHIPMENTS
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18. About UPS
UPS is a global leader in logistics, offering a broad range
of solutions including transporting packages and freight;
facilitating international trade, and deploying advanced
technology to more efficiently manage the world of
business. Headquartered in Atlanta, UPS serves more
than 220 countries and territories worldwide.
UPS | SENSITECH
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19. About Sensitech
Sensitech Inc. is a world leader in supply chain visibility.
Our innovative monitoring products and services
help to maintain the quality, integrity and security of
our customers’ valuable products at every step in
their journey, all around the world. For more than 25
years, leading companies in the food, pharmaceutical,
industrial, consumer goods, and other industries have
relied on Sensitech to help protect their products—
and their bottom lines.
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