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1 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Seminar hosted by ELPRO and Envirotainer
Seminar Post Event Report May 3rd & 4th 2016 in New Jersey, USA
2 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Thank YouThank you to all those that participated in the second Leading Minds Seminar in Princeton New Jersey.So many of you came eager to learn – what a great start! Thank you for your contributions during discussions. A massive thank you to all the speakers, discussion leaders and chairperson. These meetings are «make or break» based on the willingness of speakers to collect their experience and present it in a meaningful way to participants.
Seminar Objective:
The purpose of the seminar was to educate participants
on how to comply with global GDPs and put each of the
components together to create a cost-effective, compli-
ant temperature control chain.
As partners in cold chain pharma for decades, ELPRO and
Envirotainer realize sometimes you need more than just
«information overload» at a conference. Rather you need
a focused group of people, concentrating on developing a
complete solution that you need.
We received positive feedback that the seminar achieved
the right environment to share experiences, ideas and
provided practical information for you to shake things up
(and improve!) back at the office.
We hope the problem-solving format of the seminar,
translates in the post event summary of sessions below
and is a useful document to share with colleagues, project
team and management.
We look forward to seeing you again at the next
Leading Minds Seminar. Tell your Midwest colleagues
about LMS Chicago in early November this year, dates TBC
on www.elpro.com/elproseminar/
Sincerely,
Participants:
66 people registered for the Princeton Leading Minds
Seminar, with most attending the User Groups the second
day. Most participants were pharmaceutical manufac-
turers with a handful of transportation partners.
3 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Early FindingsThe Leading Minds Seminars are geared toward creating dialogue between practitioners. Something we call FUELs. A Fusion of Useful Experiences in Logistics and Storage. With at least half of the Princeton program being discussion-based, we collected participant’s feedback via a survey before the seminar started to help plan the discussions. Below were some of the early findings on the group’s beliefs and experiences.
What is your function?
Maintaining temperature during last mile distribution: What are the biggest challenges that you face during this step of the supply chain?
Are you aware of a number of new regula tions across the globe that cover environmental mapping of facilities and chambers, and if so, are you changing your practices at all?
Approximately, what % of your temperature sensitive shipments (refrigerated) and temperature method mo-nitored at 100% rate?
Do you currently use a central data base for your tem-perature data?
10
Logistics, Transport, Supply ChainQualityRegulatory/Compliance
20 30 40 50 60%
Clinical SupplySupply chain Partner (airline, forwarder, 3PL)Other
10Wholesalers/pharmacies unwilling to send temperature data back
Pharmacies uncertainly how to handle temperature control
products/lack of awareness
Cost of thermal packaging and/or temperature monitoring solutions
Cost of compliant/qualitive distribution
Packaging qualification
Lack of resources
Absence of controlling processes and systems
Other
20 30 40 50%
10
Yes, aware, no not changing practicesYes, aware, will change once we come to do a mappingYes, aware, have initiated mappings based on new regulationsNot aware of regulatory changesOther
20 30 40 50%
10
0%<25%
20 30 40 50%
25–50%50–75%
>75%100%
10 20
10
Yes
20 30 40 50 60%
No
10 20 30 40 50
4 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Regulatory Inspector Presentation: Good Distribution Practices in Today’s Pharmaceutical Supply ChainIan Holloway | Senior GMP Inspector, MHRA
Ian discussed several new and updated regulations in
Europe over the past year that affect temperature control
professionals. Practical points from the guidance docu-
ments included:
Risk Mitigation:
- Map the route with all the key steps
- Monitor the performance against KPIs
- Be aware of cultural differences
- Understand geo-political influencers
- Use simulated failure exercises
- Ensure comprehensive technical agreements
- Schedule regular external audits and self-inspections
- Document training programs
- Make contingency arrangements
- Procedures available and documented
for inspection at all times
- Identify local «fixers/contacts» in market
GDP for Active Substances and Excipients:
- Records of purchase, receipt, transportation and
manufacture should be retained for one year after
expiry date of API
- APIs must be stored and transported according to
«written instructions» for temperature and humidity
- Risk assessments must be carried out on excipients
for human medicines by 21 March 2016 – for each
separate manufacturer
- Excipients show now be classified as low,
medium or high risk – based on:
- Environmental control, storage and transport
conditions
- Supply chain complexity
- Stability
- Packaging integrity
Seminar SessionsData Integrity for Cold Chain:
- Applies to all records not just computers
- Use audit trails used where possible
- Ensure reliable recovery of data from archives
- Suitable password control; and user levels
and privileges
- Follow ALCOA: Attributable; Legible;
Contemporaneous; Original; Accurate
Interpretation of GDP for Temperature Sensitive Shipments in the Pharma Supply ChainStephen Maietta | Head of Global Key Accounts,
Envirotainer
Stephen discussed core elements to GDP practices in the
pharmaceutical supply chain including:
Core Team and Measurable KPIs:
- Quality agreements
- SOPs
- Partnerships
- Shared risk and reward
- Where does accountability start and stop?
Collaboration is key!
Transport Evaluation with Measurable KPIs:
- Evolution charting through supply chain
- Consistent improvements
- Useable data
- Implement data
- Value added services
Collaboration Drives Visibility:
- Quality management system
- Qualification and validation
- Planning and assessment
- Quality agreements and SOPs
5 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
- Measurable KPIs with process
- Repeatable processes
- Data collection
- Reporting
- Regular training
- Transparency
- Continuous improvements
Temperature Sensitive Products:
Pharma; Bio Logics; Consumer/OTC; Medical Device
- Transport options (air, ground, ocean)
- Risk profile
- Speed to market
- Cost
- Tri party contributions
- Variables for identification
Developing a Robust Temperature Controlled Logistics StrategyNish Chudasama | Group Leader Integrated Supply
Chain Operations, Bristol-Myers Squibb
Nish discussed industry trends over the past ten years as
regards temperature controlled logistics, including:
- Goals: patient safety and product integrity
- What: temperature (CRT, refrigerated, frozen);
valuation (commercial, replacement value)
- Where: foot print (local, domestic, international);
customers (intra company, wholesale, point of
consumption)
- How: internal (logistics, sourcing, quality,
package technology, customs, security); external
(Airlines, Forwarders, temperature monitoring
provider, active and passive provider)
- Domestic Logistics: using parcel shipments; LTL; TL
- International Logistics: using multi modal;
multiple hand offs; multiple layers; longer transit;
border crossing; customers. Decision criteria includes
product value/payload; lane/destination; logistics
partner
- Alternative Mode: Ocean – longer transit times;
lanes ideal for mature products with consistent and
stable volumes; reluctant to carry high value
- In transit Thermal Mapping Study and in transit
Monitoring requirements
- Other important internal partnerships to get online:
quality; package technology; customs / trade; security
6 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Problem-Solving Small Group Discussion
A) Implementing a Global Data Monitoring System Part I – Getting the Project Moving Internally, Securing Senior Sponsorship, Defining New System Requirements & SOPs
Discussion Leaders:
Katherine Woodcock | Senior Specialist,
Clinical Business Operations, Biogen
Luke Kucala | Senior Logistics Specialist,
Clinical Drug Supply, Biogen
Terri Montes | Informationist, Knowledgent
*Of the 11 pharma manufacturers represented, only
3 had any form of temperature performance database.
Biogen’s Experiences Thus Far:
- The database was designed to allow for informed sta-
keholder communication and total Cold Chain Process
management.
- A dashboard is used to communicate a snapshot of per-
formance with project owners and senior management.
- One of the most positively received features has been
the customizability of alarm notifications.
- One desired function was the ability to match alarms
with delivery times, in order to avoid an excursion being
displayed after a particular shipment had already con-
cluded.
- Biogen can determine whether a sensor’s data has not
been uploaded after shipment because the shipment
will still be marked “open” in their csv file from data-
base. This allows them to ensure data available from all
shipments.
- Mobile connectivity to database has allowed for a more
fluid working environment.
- No significant add of workload for employees to add
or distribute data, only slight increase in timeline for
warehousing sensors and ensuring proper return.
Problem-Solving Small Group Discussion
B) Weak Points in the Data Supply Chain – Where and How Would More Logistics Data and Visibility be Helpful?
Discussion Leader:
Oskar Hjartquist | Business Developer, Envirotainer
Background:
- Industry colleagues shared pain points for pharma-
ceutical manufacturers in different parts of their
logistics flow.
- Envirotainer is working on a technical platform to pro-
vide near-live data from shipments, globally.
Discussion Highlights:
- Overall visibility today is low, and hence reaction times
to any issues are very long.
- Potential solutions to those issues were discussed, and
the value of better data and information was empha-
sized.
- A recurring theme in the discussion was that of indus-
try-wide collaboration and specifically using common
standard(s) to improve knowledge sharing between
pharmaceutical manufacturers.
Group Suggestions for Change:
- A knowledge-sharing, social platform in «TripAdvisor
style» for Pharmaceutical supply chain professionals,
to exchange ideas and experiences of trade lanes,
packaging and partners.
- A data-exchange of temperature profiles from ship-
ments between companies; and a common standard
for how to place the temperature loggers in each
shipment.
7 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Problem-Solving Small Group Discussion
C) Handling Ultra Cold Temperature Clinical and Commercial Shipments and Their Data Monitoring Challenges
Discussion Leader:
Bruce C. Simpson | Director, Commercial Operations,
Fisher BioServices
Ultra-low or cryogenic shippers and shipments are a
niche market for certain applications, such as for shipping
material at -150 °C for personalized cellular therapies and
regenerative medicines. Bruce had a 500 unit dry ship-
per and 100 unit dry shipper with various canisters for
demonstration and discussion.
Key Learning Points:
- The industry is shifting towards biologics, and more
personalization, such as home delivery and self-dose
for clinical trials. The challenge to meet this need is
to have a shipping system that is disposable and easy
enough for the patient to use.
- The current shipping system consists of a vapor shipper
and a data logger. Shippers are «charged» prior to ship-
ment. The shipper is qualified to verify that it can hold
the charge for the allotted time. There will be some
time (about 1 day) lost due to heat transfer through the
data logging sensor. The data logger that Fisher uses
does not require software or hardware to download
data at the receiving site.
- Limiting factors are with the shippers themselves,
which are often mishandled by the carriers. For ex-
ample, placed on their side or upside down, which can
damage the samples and diminish charge in the shipper.
Also «wicking» of temperature out of the unit can hap-
pen sometimes depending on the design of the unit.
- The shipper may also see the «venturi effect» during
air transport when analyzing data, which causes false
high and low temperatures for the shipment. To miti-
gate this, Fisher has chosen a «disc» sensor, a circular
sensor with a certain diameter, to provide a greater
surface area to eliminate temperature excursions. The
other alternative is to place a sensor directly in the
ballast of the shipper, which will give greater visibi-
lity to the actual temperatures of the samples during
shipment.
- As a logistics case study, Bruce discussed a partnership
with a large pharmaceutical company to transport a
valuable, high profile drug, hundreds of samples per
shipment. There was not one delay or lost shipment.
8 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Problem-Solving Small Group Discussion
D) The Future of Monitoring, and the Present Truth of the Total Cost of Distribution
Discussion Leader:
Ben Romero | Senior Packaging Engineer, formerly
Genentech & President, CoolPack
Starting Points:
A pre-seminar survey was conducted with 18 respon-
dents, which helped set the scene for discussion, results
included:
- About greater than 80% of the respondents believe that
100% monitoring is the ideal state. Some are already
doing it.
- Greater than 80% believe that the solutions are desig-
ned to work against the most extreme environmental
conditions. That meant either an extremely large ship-
per for most of them or potential lack of awareness of
a level of complexity involved in shipping. Clearly from
the discussion the latter was the case this great aware-
ness has the complexity involved in shipping. That af-
fects the proponents of the shipping containers.
- About 22% of the respondents monitor 100% of the
shipments and a similar percentage went to monitoring
less than 25% of the shipments.
- The biggest obstacle in implementing 100% monitoring
was operational challenges (e.g. SOP‘s at shipping site,
receiving site, challenges of interpretation and return
of monitor/data logger data); and cost being the other
major hurdle.
Group’s Feedback and Learning Points:
- Impossible to 100% monitor in the last mile because
people change day to day, and there are little if any
regulations on this part of the supply chain.
- The group worries about the patients and wants to
offer a guarantee. Thus 100% monitoring offers that
guarantee to prove its safe; and that you should as
best practice monitor 100% unless you can document
your logistics processes.
- Even though complexity of supply chains grow, manu-
facturers are conducting long-term risk based perfor-
mance studies, i.e. lane qualification to define their
monitoring approach and document their logistics pro-
cesses.
- What is total cost? When looking at distribution, the
cost of materials, assembly, conditioning and shipping
costs are considered the total cost – but, what about
qualification and risk related costs? Lane qualification
has many variables, and even with testing, how can you
be sure that you are not taking too much or too little
risk?
- There was one cost sometime forgotten – that is cost
of excursion investigation and the cost related to if
a lot is put on hold because it is not an investigation
being made, what is the cost of that? The perception is
100% monitoring means costs goes up; and a risk based
approach costs go down. But is that true in practice?
There was one participant in the group that had an ex-
ample of a going from no monitoring to 100% monito-
ring and they actually achieved cost savings from a full
cost perspective.
- If monitors and indicators are used in the last mile, re-
gulators require any submission with all rental informa-
tion including how the recipient is going to interpret
that monitor or indicator. That information is being re-
quested to be put into the drug file now by regulators.
9 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Community Forum Discussion:
Defining Your CRT Policy
Moderator:
Michael English | Associate Director Engineering, Merck
Michael led an open discussion amongst the group to
share experiences with how to deal with auditor’s questi-
ons on CRT product handling.
The basic premise was most companies fall into one
«camp», as outlined by EFPIA 1) Those who use stability
data during shipping 2) Those who use a stability budget
if something goes wrong with the product and have to de-
termine the impact to the product. Key discussion themes
included:
Definitions Vary – Let’s Get on the Same Page:
- Depending on where you ship there are different defi-
nitions of Controlled Temperature products. In the US,
the USP defines CRT as +20 °C..+25 C°; whereas in Eu-
rope it can be <30C° for the same product with same
stability data. How do you ship universally then, assign
label claim information? Bottom line, use the data to
decide what’s right for your product. Opportunity is to
create standards for labeling and the storage tempera-
ture requirements.
- What does Room Temperature mean? It depends. The
requirement is to ensure consumer safety, but then
again consumer could be at home, in physician office or
hospital. Are those temperatures consistent? No.
- Cool dry place – what does that mean? Again here in lies
further ambiguity.
- Ambient – what does this mean? In Europe people use
it interchangeably with CRT, but is that true?
- IATA Perishable Cargo Reg defines ambient as = «nor-
mal room temperature»
- Pharma company X, ambient = «uncontrolled tem-
perature, prevailing temperature in working environ-
ment, not the same as CRT»
- Another example ambient = «uncontrolled tempera-
ture and humidity conditions existing in a workplace
or other location»
Be Prepared for Auditor’s Questions on CRT Shipping
- «Show me data that supports those shipping ranges.»
You could show them:
- Results of OQ. For specific product or mode.
- Risk mapping – technical assessment, FMEAs,
risk assessments
- Live data
- «How are you maintaining this storage requirement
during shipping? Country X over here has a package
insert says ‹Do not freeze›. But your labels from HQ
don’t indicate this.»
- Routinely audit your own processes!
- Expectation is for a consistency across all
shipping sites.
- «Your distribution site practices seem sufficient, but
can I see your corporate policy on temperature cont-
rolled shipping?»
- Be ready to provide back up documents.
- «What are your allowable shipping ranges and how can
you prove it?»
- Quality agreement for 3PL
- Stability budget and policy that lists out outside of
storage allowance for each leg of lifecycle.
- Temperature data from random shipments, to show
auditor your controlled processes. Can you explain
the excursions, i.e. result of CAPA investigation?
- «Show me your shipping qualification.»
- First it’s best to ask the regulator to elaborate on
what specifically they want to see. Sure you can show
an OQ or PQ – but that’s only temperature.
- Be prepared to answer questions on product impact
relative to temperature, shock and vibration, humi-
dity, light sensitivity, delivery metrics. For example,
the increasing number of biologics are driving regula-
tors to ask about these other key quality criteria.
- Our opportunity is to show that we are treating CRT
products similarly to products stored at refrigerated
temperatures.
- Ambient can be inside or outside. Point is – we as
an industry need to be using the same terms in the
same way.
10 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Are We Getting Too Wide with Our Shipping Allowances?
- Regulators also don’t understand why some shipping
ranges are so wide – with a stability budget allowing
temperatures of -20 °C..+40 °C, are we really exposing
our products to +40 °C for a week, continuously? No, of
course not. But the opportunity remains, if we have a
stability budget allowing +40 °C for a week, how are we
managing shipments to continuously improve towards
shipping within a narrower range?
- Historical estimates suggest that 38% of General Cargo
shipments experience sometime between +30 °C and
+40 °C. What are some options for more controlled
temperatures during shipping?
- Elevated service level above general cargo, Pharma
Service, Temp Control, Expedited or Premium Courier.
- Define specific requirements for your products,
detailed in the service level agreements. But how –
what information is exactly needed? One best prac-
tice is to use an industry standard such as the IATA
Time and Temperature Label.
- But that is usually not enough, there has to be more
communication that your standard label, such as the
airway bill.
- Use of active or passive thermal protection systems
Global Data Monitoring Pharma Industry Business Case: Preparing for Shipment AnalyticsWim Vangoidsenhoven | Independent,
Transportation and Cold Chain Practitioner
Project Experiences:
- Implemented 35+ sending sites over 6 months, site by
site, and 120 destination sites. >300 users trained using
face to face and e-learning platforms. Positive user
experiences.
- >25,000 temperature data files received in first year –
now begins the exciting analytics!
- First supply chain processes analyzed included excur-
sion ratio per freight forwarder; global evolution of
total temperature alarms; average high and low tem-
peratures for +2 °C..+8 °C shipments and CRT shipments
trend ing across two years.
Learning Points:
- A top down approach was necessary for success, from
global to local level. Global project managment defining
the framework of the solution and maintaining control
over the process and data with each local team.
- Define resources early! Project planning and perma-
nent communication are vital to success.
- The project created temperature managment aware-
ness thorughout the company; consequently improving
cold chain value stream mapping, global distribution
policy and qualification guidelines for packaging, sto-
rage, ocean containers and vehicles.
- With refined temperature management globally, they
were able to create a ’excursion allowance model’,
seperating major from minor excursions and reducing
QA processing time, by using multiple alarm zone data
loggers.
- Overall this reduced total excursions of +15 °C..+25 °C
products by 62% and by 77% for +2 °C..+8 °C ship-
ments!
- Equating to 11,000 hours/year of reduced work-
load (6.5 FTEs)
- Reduction of lost sales equal to $USD 61 M/year
Efficiency and Strength of the Solution
Highly Depends on:
- Awareness level of the users and stakeholders
- Maturity of the company in terms of temperature
management
- Change management process
- Continuous follow-up on system and user experience
- Process setup (centralized versus decentralized)
11 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Community Forum Discussion: Transport Qualification
Moderator:
Cyril Winkler | Head of Product Management, ELPRO
Panelists:
Timothy Sersen | Manager, Global Supply Chain
Quality Program, AbbVie Inc.
Ben Romero | Senior Packaging Engineer, formerly
Genentech & President, CoolPack
This session was an open group discussion. It is clear:
there are many different approaches, methodologies
and beliefs when it comes to transport qualification and
supply chain mapping. Some companies have a transport
qualification guideline, SOPs in place or even a dedicated
team. Whereas other companies are still defining what
transport qualification means to their company and how
to meet evolving regulatory requirements.
The report Cyril mentioned during the discussion, a bench-
marking study comparing 5 different pharmaceutical
manufacturer’s approaches, can be found via the dropbox
link sent in the post-seminar email to all particpants. If
you do not have it, please email [email protected]
The Detailed Benchmarking Report Compares
5 Different Pharmaceutical Manufacturer’s
Approaches to:
- Who – to what extent – is involved
in a transport qualification
- Who owns the stablity data
- How to evaluate strengths and weaknesses
of shipping lanes
- How risk analyses are performed on
network/lanes; transport modes; packaging
- What techniques or tools are used for risk analysis
- How are networking mappings performed
- Risk analysis and treatment of higher value products
Problem-Solving Small Group Discussion
A) Implementing a Global Data Monitoring System Part II: Bringing Inline External Partners, including Clinical Sites, Manu-facturing, CROs and Logistics Partners
Discussion Leaders:
Katherine Woodcock | Senior Specialist,
Clinical Business Operations, Biogen
Luke Kucala | Senior Logistics Specialist,
Clinical Drug Supply, Biogen
Terri Montes | Informationist, Knowledgent
*Following the morning session about getting the buy-in
on the same topic, the implementation of a global stan-
dard for temperature monitoring was discussed in this
session.
Key success factors for implementation in this complex
environment, with a mix of internal and external parties
(CMOs) and a global scope were, among others:
- Centralizing the configuration and setup of system and
loggers
- Clear processes and procedures for all parties to follow,
aiming to minimize human errors when the standard
was operationalized, and last but not least
- A very good user visualization, that allows everyone
from senior management to analysts to follow up the
status and issues in their supply chain.
12 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
Problem-Solving Small Group Discussion
B) Maintaining Performance and the Part-nership with Solution Providers Post Im-plementation
Discussion Leader:
Jim Bacon | Principal, Stay Cool Logistics Consulting LLC
A pre-seminar survey was conducted with 18 respon-
dents, which helped set the scene for discussion, results
included:
- 82% felt it is extremely important to maintain a rela-
tionship with partner suppliers.
- 76% felt that a combination of personality and know-
ledge are important attributes when developing a
relationship.
- 50% of manufacturers believed in meeting routinely,
and other 50% said meeting only when issues arise.
Group Feedback and Lesson Learned:
- There always should be a formal process of selecting
suppliers, most of the group agreed this is a quality
audit or quality vendor questionnaire.
- A «business audit» can be used along with the qua-
lity audit to gauge the «trust» factor o and understand
the business culture and behaviors of the supplier or-
ganization. Ultimately the provider’s ability, willingness,
and processes to deliver a customer experience in line
with expectations.
- The combination of business and quality audit also
helps to gauge the «competency» factor; the provider’s
ability to deliver products and services that meet or
exceed customer user requirements.
- The group stressed the importance of routine reviews,
commonly referred to as QBR’s (Quarterly Business
Reviews). These are critical in measuring performance,
discussing and resolving issues, and learning about
new developments (both customer and provider).
- Jim introduced an overall process that has worked in
his former roles: PLAN > EXECUTE > REVIEW as a con-
tinuous loop. This takes us through define, DQ, OQ, PQ,
document, train, implementation, routine review, and
repeat (continuous improvement).
D) Temperature Mapping and Humidity Considerations for Warehouses – When, How, Why to Map or Perform Full Qualifications based on New Regulatory Guidelines
Discussion Leaders:
Micalyn Harris | Vice President, Sales & Marketing
North America, ELPRO
Teresa Parayil | Key Account Manager, ELPRO
Starting Points:
A pre-seminar survey was conducted with 18 respon-
dents, which helped set the scene for discussion, results
included:
- It was a pretty event split – between those who were
aware of recent regulatory changes on cold room
mappings, and those who were not aware. Of the
55% that were aware, only 30% were not currently
changing practices.
13 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
- Nearly 50% of respondents said QA drives temperature
mappings of facilities and chambers, whereas the other
departments included global temperautre councils or
COE; logistics and warehousing.
Key Points:
- Mapping is essentially the recording of climate con-
ditions in a three-dimensional area to identify whe-
re various products should and should not be stored.
Although regulation bodies differ by country, it is
consistently recognized that equipment and proces-
ses should be respectively qualified and/or validated
before commencing use and after any significant
change (such as repairs or maintenance), and tempe-
rature mapping is the appropriate way to thermally
qualify your warehouse.
- USP Guidance <1079> says «the size of the space, loca-
tion of space heaters, sun-facing walls, and geographic
location of the warehouse, should all be taken into
consideration when mapping a warehouse/storage
facility.»
- The study should be conducted long enough to show
trends, and industry standards conclude that conditions
should be recorded for a minimum of three consecutive
days.
How to Conduct a Temperature Mapping of a Facility,
Cold Room or Chamber:
- Step 1: Define acceptance criteria (i.e. acceptance
criteria is stated as +15 °C..+25 °C and ±5 °C is noted
to allow for excursions).
- Step 2: Collect data about the critical components of
your facility, including blueprints, dimensions, racking
systems/organization system locations, HVAC plans and
insulation materials. Also, take into consideration the
areas of risk (i.e. areas that may experience environ-
mental fluctuations).
- Step 3: Once you analyze your space, then you can
determine the number of data loggers you will need.
Temperature and humidity data loggers should be
setup strategically in a uniform pattern throughout
your facility.
Thank you again for attending the Leading Minds Seminar in Princeton.
Tell your colleagues about the upcoming Fall
Leading Minds Seminar in Chicago in early November,
dates TBC on www.elpro.com/elproseminar/
Your partners
ELPRO & Envirotainer
- Step 4: As you collect information, write your proto-
col, which will include acceptance criteria, will specify
the number of data loggers, data logger locations, data
acquisition intervals and study duration.
- Step 5: Once you have the plan, buy data loggers,
program them, place data loggers and start them.
- Step 6: Collect data over several days to draw conclu-
sions based on the PDF reports from the data loggers.
- Please feel free to call ELPRO for any help or advice on
temperature mapping.
14 POST EVENT REPORT | LMS NEW JERSEY, USA | MAY 2016
www.elpro.com www.envirotainer.com
About the Seminar Hosts
For nearly 30 years, ELPRO has been a leading Swiss
manu facturer of innovative monitoring solutions and
data loggers for documenting environmental conditions
in cold chain transportation, production facilities and
warehouses. ELPRO partners with clients to develop
solutions that integrate ELPROs high-quality measure-
ment components into their business processes. Clients
include biotechs, diagnostic manufacturers, and top 20
pharmaceutical companies. As the inventor of the LIBERO
PDF Logger, ELPRO supports pharmaceutical and health-
care companies around the world in simplifying their
cold chain while having less manual work thus reaching
quicker release times. ELPRO’s US subsidiary has been
established in Marietta, OH since 2003 with a full turnkey
support and technical staff.
Envirotainer is an industry leader in active temperature-
controlled containers for air cargo on a rent-it-when-
you-need-it-basis, in an open-platform global network.
We also offer related services that ensure correct tem-
perature throughout the transportation – from loading
to delivery. No matter how long the journey, or whether
cooling or heating is the key requirement. In the indus-
try this is called an unbroken cold chain. Envirotainer is
a Swedish company, and all production and develop-
ment takes place in Tallbacksgatan 12, Rosersberg, loca-
ted between Stockholm and Uppsala. But our business
is truly international. One of our greatest competitive
advantages is our global network of partners within the
freight forwarding and airline industries, as well as our
presence at most of the world’s major airports. We also
have our own operations centers in Singapore, Dallas and
Frankfurt.
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