Download Post Event Report

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


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.


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


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


- 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


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.


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.



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.



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.


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.


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)


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


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.



B) Maintaining Performance and the Part-nership with Solution Providers Post Im-plementation

Discussion Leader:

Jim Bacon | Principal, Stay Cool Logistics Consulting LLC



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:



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.


- 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.


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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