CP21/23: PRIIPs - Proposed scope rules and amendments to ...
Laminar Medica Company Presentation...•Fully qualified and tested to ISTA 7D & 7E Series •Common...
Transcript of Laminar Medica Company Presentation...•Fully qualified and tested to ISTA 7D & 7E Series •Common...
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Laminar Medica
Company Presentation
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ContentsModule Topic
1 Laminar Medica
Overview
2 Product Range
3 Why Choose Laminar
Medica?
4 Insulating Materials
5 Refrigerants
6 Tech
7 Modularity
8 Global Availability
9 US Products
Module Topic
10 Asia Products
11 German, Swiss & Austria
Products
12 Global Mapping Study
13 Environment
14 Key Accounts
15 Cargo Range
16 AmbiTech™ Global range
17 ChillTech™ range
18 Customer Details
19 Contact Details
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Laminar Medica Overview
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Laminar Medica Ltd
• Pioneers in temperature controlled packaging since
1975
• Focused on the pharmaceutical and biotech industries
• Bespoke and standard ‘off the shelf’ products
• Manufacturing centres in UK, Czech Republic, North
America and Singapore
• Laminar Medica is the only manufacturer of insulated
shipping systems to hold 4 quality standards
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Product Range
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Product Range
Flexible options include:
• Pre-qualified products
• Bespoke systems
• Modular solutions
From 2 litres to 1313 litres payloads, both reuse or
single journeys from 4 to 120 hours
Temperature bands include:
• Freezetherm ® (-0°C)
• Chilltherm® (+2°C to +8°C)
• MediSorb ® MSMC (+15°C to +25°C)
• AmbiTech™ Global (+15°C to +25°C)
• ClimiTherm® (+2°C to +25°C)
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Why Choose Laminar Medica ?
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Why Choose Laminar Medica?
• As a “Pioneer” in temperature controlled packaging we
have a knowledgeable and skilled workforce
• We are focused on the pharmaceutical and biotech
industries, unlike a lot of our competitors who also work
in food and construction sectors
• With four operational facilities spanning the globe
including North America, Europe, and Asia we can
ensure it is easier for customers to specify our products
across their regional operations
• In house manufacture of all key components ensures
quality control and flexible lead times
• Laminar Medica is the only manufacturer of insulated
shipping systems to hold 4 quality standards
• A financially stable supply partner as part of the CliniMed
Group
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Insulating Materials
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Insulating Materials
Choice of insulating materials used in our shipping systems:
Expanded Polystyrene (EPS)
• Good quality insulator
• Cost effective
• Lightweight
Graphite Foam
• Better insulation properties than standard EPS
• Robust
• Does not require an exterior carton
Vacuum Insulated Panels (VIP)
• High insulating properties
• Higher Cost
• Compact
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Refrigerants
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Refrigerants (standard & PCM)
• Medicool ® water based coolpacks with foam
• MediTray ® gel formula coolpacks
• Bottlepacks hard cased coolpacks
• AmbiSorb™ PCM packs for +15°C to +25°C
• Mediphase® -15 PCM for -25ºC to -15ºC
• ChillPhase ® PCM packs for +2°C to +8°C
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Research & Development
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Research & Development
• Technical and R&D laboratories provides key technical
and project management support
• One of Europe’s largest test and qualification
laboratories
• Multiple environment chambers, plus advanced software
analysis tools
• ISTA trained packaging technologists
• Dedicated R&D laboratory
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Modular Concept
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Modular Concept
Same footprint, different durations
• You choose the pack out that best suits your required
duration
• You do not use a system that is over-engineered for
your needs
• Often resulting in fewer components and less cost
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Modular Concept
Same footprint, different temperature bands
• Our systems are qualified within different temperature
bands
• You choose the one that best suits the stability data
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Modular Concept
Same footprint, different payloads
• Increase payload with capacities with
additional rings
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Global Reach Strategy
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Global Reach Strategy
With four operational facilities spanning the globe
including North America, Europe and Asia we can ensure
it is easier for customers to specify our products
across their regional operations:
• Consistent high quality product available worldwide
• Reduced lead times and delivery costs
• Reduced environmental impact from local
manufacture
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Global Locations
Europe
Laminar Medica Ltd(Tring, United Kingdom)
Laminar Medica (CE) s.r.o(Vodnany, Czech Rep)
Pharma Logisticspartner(Hamburg, Germany)
North America
Laminar Medica Inc. / Radford 3PL(Mansfield - MA, USA)
Asia
Aeris Dynamics Pte Ltd(Singapore)
Aeris Dynamics Packaging India (Mumbai, India)
Aeris Trading (Shanghai) Co. Ltd(Shanghai & Beijing China)
Aeris Korea Co. Ltd(Gyeonggi-do, South Korea)
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Products available in North America
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Products available in N. America
• North American production and distribution of insulated
shipping systems designed and developed by Laminar
Medica Ltd
• Consistent quality standards worldwide
• Reduced lead times and delivery costs
• Over 30 prequalified shipping systems available
• Refrigerated, controlled room temperature and frozen
systems available
• Capacities from 4 liters (0.14 cu ft.) to 103 liters (3.6 cu ft.)
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Products available in Asia
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Products available in Asia
• Asian production and distribution of insulated shipping
systems designed and developed by Laminar Medica Ltd
• Consistent quality standards worldwide
• Reduced lead times and delivery costs
• Over 30 prequalified shipping systems available
• Refrigerated, controlled room temperature and frozen
systems available
• Capacities from 4 litres to 498.3 litres
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Products available in Germany, Austria
& Switzerland
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Germany, Switzerland & Austria
Through a partnership with Pharma LogisticsPartner we are
able to offer customers in Germany, Switzerland and Austria:
• Consistent quality standards
• Reduced lead times
• Smaller quantities
• Next day delivery
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Global Mapping Study
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Global Mapping Study
Laminar Medica conducted a Global Mapping Study project
with a major logistics partner to develop realistic
temperature profiles
Goal:
Measure ambient temperature profiles from the ACTUAL
clinical trials network
Collection enough data for statistical significance over all
seasons (23 months +)
369 global shipments including dual airfreight legs
Benefits:
Identify lanes / areas of extreme ambient temperatures
Use the data to validate current / develop new packaging
testing profiles
Develop appropriate packaging for the lanes
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Laminar Medica uses the data from a Global Mapping
study to determine standard profiles
72h00 range: “Regional profile”
96h00 range: “Global profile”
Our Standard Profiles
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Environment
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We are committed to lowering our own environmental impact
and raising our clients’ awareness of environmental issues:
• Using materials that are extremely resource efficient
• We have implemented the BS EN ISO 14001
environmental management system which ensures we are
working in an environmentally sustainable manner
• 85% recycling rates in waste streams
Environmental
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Key Accounts
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Key Accounts
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Introducing the Cargo Range
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Introducing the Cargo range
• Range of aircraft compatible bulk cargo shipping systems
• Cost effective alternative to “Active” ULD containers.
• Designed to optimise the use of space on LD7 air pallet
Product External Dims Internal DimsPayload
(litres)
Payload
(pallets)
Cool
Packs
CTC506 1200 x 1000 x
1295mm
890 x 695 x
825mm506L 28 x MT3T
CTC1313
(¼ PMC)1568 x 1197 x
1592mm
1270 x 899 x
1150mm1,313L
1 euro
pallet40 x MT3T
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Cargo Research & Development
To ensure that the design concept was “fit for purpose” our
R&D team carried out the following market research:
Industry requirements survey (incl. freight forwarders,
airport facilities, airlines, couriers/3PLs and
pharmaceutical companies)
Functional requirements survey (physical restrictions for
customs, airport and airline facilities)
Competing products survey (bench mark systems in
terms of performance, ease of assembly and payload
capacity)
We are confident you won’t find a better system
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Customer Benefits
• Class leading payload capacities
• High performance insulating material
• Flat packable for storage and return
• Multi use sustainable solution
• Minimal components for quick and easy packout
• Minimal waste packaging
• Visual coolpack check during assembly to ensure
correct packout
• Validated for long haul shipments (4/5 days)
• Tested to our Global profiles
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Assembly Video
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Passive versus Active
Passive Packaging Active Packaging
Can it be packed on-
site? Coolant conditioning may
be required
May require specific
handling equipment
Can the system be
customised to
requirements?
Can be customise to suit
the customer’s needs
Not customisable
Can it heat and cool? Can maintain
temperatures and cool
Units with heating only are
limited
Are they available
globally? Available locally via
multiple carriers and routes
Dependent on local
availability and route
Are they available
immediately Yes can be kept on the
shelf
Dependent on shipping
origin and destination
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Passive versus Active
Passive Packaging Active Packaging
Does it need
management during
transportation?
Once sealed it needs
no further intervention
Requires management
during transit
Can it be used for one-
way shipping? Designed to be cost-
effective for single use
Multi-use only and must
be returned to base or a hub
Can it handle extreme
ambient temperatures? Multiple coolant
configurations can be
adapted for different
extremes
Heating and cooling units
available to handle extreme
temperatures
Are there any special
freight handling
requirements?
Classified and handled
as temperature sensitive
and stored in a controlled
warehouse ready for
loading rather than left
airside
Units using dry-ice are
classified as “dangerous
goods” and can attract a
premium freight charge
Can it be used to
distribute products any
where?
Can be sent via air to
any global destination
Can only go via certified
handlers and not to every
country
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• PCM is short for Phase Change Material
• In simple terms, they are substances that absorb, store and release thermal energy during the process of melting and freezing
• This makes them ideal for temperature control applications
What are PCMs?
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Why are PCM Cargo systems better?
Provide exceptional temperature protection so perfect when cargo is rare or very expensive
Provide exceptional stability for longer so perfect when shipping from / to / or through extreme temperatures or across hemispheres
All year pack outtherefore no need to change from summer to winter configuration so easier for our customer and less likelihood of error
Able to hibernate if cargo is delayed and can be refrigerated. This can extend the duration even further protecting cargo from compromise
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Introducing ChillTech™ PCM Cargo
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ChillTech™ PCM Cargo range
CHC476CHC1313
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ChillTech™ PCM Cargo range
• ChillTech™ Cargo- CHC476 - 476 litre capacity- CHC1313 - 1313 litre capacity
• Fully qualified and tested to ISTA 7D & 7E Series
• Common PCM bottle pack CP21 across both products
• PCM is sustainably sourced and delivers reliable and robust temperature control, even in the most challenging conditions
• If cargo is refrigerated during transit, PCM will hibernate and re-activate when ambient temperatures rise again, prolonging the duration of the system
A range of Cargo systems designed to be aircraft compatible
CHC476
CHC1313
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Packing diagrams
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Data Sheet
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Introducing AmbiTech™ Global
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AmbiTech™ Global
Background to development:
• Revised GDP regulations require organisations to be compliant with new risk
based principles on how all APIs & medicines are shipped
• The shipment of ambient (+15°C to +25°C) products is the most significant
regulatory change, posing a challenge to established supply chain procedures
to maintain compliance
• The AmbiTech™ Global range of +15°C to +25°C shipping systems uses
our bespoke AmbiSorb PCM to deliver a
superior level of temperature control, even
for shipments to the harshest of climates
• Tested to ISTA temperature profiles from the
7D & 7E Guidelines
• 7 sizes available from 4 - 65 litre capacity
AmbiTech™ Global
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Customer benefits
• Fully qualified range of ambient +15°C to +25°C
shipping systems available off the shelf
• Provides superior protection for up to 120 hours
giving total peace of mind
• Uses AmbiSorb™, our bespoke inorganic salt PCM
which is economical and non-hazardous
• Excellent stability in extreme cold ambient
conditions
• High performance in extreme ambient conditions
over long durations
• All year pack configuration for simplified pack out
reducing risk of error and saving time
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Product details
G22
G4
G43
G65
G9 G20
G17
AmbiTech™ Product External dimensions (mm)
Available dimensions(mm)
Available volume (l)
Tare weight (kg)
AmbiTech™ G4 454 x 404 x 330 240 x 185 x 100 4.4 12.4
AmbiTech™ G9 470 x 470 x 407 245 x 245 x 160 9.6 17.6
AmbiTech™ G17 470 x 470 x 532 240 x 240 x 300 17.3 23.4
AmbiTech™ G20 569 x 513 x 536 355 x 280 x 210 20.8 29.2
AmbiTech™ G22 681 x 501 x 422 375 x 283 x 210 22.3 28.3
AmbiTech™ G43 569 x 513 x 814 355 x 280 x 435 43.2 46.1
AmbiTech™ G65 681 x 501 x 737 445 x 283 x 515 64.9 44.8
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Data Sheet
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Introducing ChillTech™
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High performance +2°C to +8°C PCM systems
• Fully qualified range of +2°C to +8°C shipping systems
• Tested to ISTA temperature profiles from the 7D and 7E Series
• Uses ChillPhase™, our sustainably sourced organic PMC which delivers
reliable and robust temperature control, even in the most challenging
of conditions
• If cargo is refrigerated during transit, PCM will hibernate and re-
activate when ambient temperatures rise again, prolonging the duration
of the system
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ChillTech™ Packing Diagrams
ChillTech™
Regional
48-72hrs
ChillPhase™
organic PCM
rigid bottle packs
EPS insulation
ChillTech™
Global
>96hrs
VIP Booster
Panels
ChillPhase™
organic PCM
rigid bottle
packs
EPS
Insulation
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ChillTech™ Regional
• Uses PCM & EPS thermal insulation to offer protection for 72+ hours
• ChillPhase™ organic PCM delivers reliable and robust temperature
control, even in the most challenging of conditions
• 4 sizes to choose from: 5, 10, 20 and 40 litre
• All year packing configuration simplifies pack out
• Euro pallet compatible footprints for efficient shipping and storage
R5
R10
R20
R40
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ChillTech™ Global
• Combines PCM, EPS & VIP insulation for ultimate thermal protection
for 96+ hours
• ChillPhase™ organic PCM delivers reliable and robust temperature
control, even in the most challenging of conditions
• 4 sizes to choose from: 5, 10, 20 and 40 litre
• All year packing configuration simplifies pack out
• Euro pallet compatible footprints for efficient shipping and storage
G10
G5G20
G40
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Payload dimensions and volumes
• ChillTech™ Regional – ChillPhase™ PCM & EPS, protection for 72+ hours
• ChillTech™ Global – ChillPhase™ PCM, EPS & VIPs, protection for 96+ hours
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Data sheet
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Summary
• Range of high performance PCM
+2°C to +8°C shippers delivering
exceptional temperature control
• Choice of Regional or Global offering
72+ and 96+ hour protection
• ChillPhase™ PCM with hibernation
feature which can prolong the duration
of the system
• 4 sizes in each range with common
ChillPhase™ packs across
corresponding Regional and Global
size
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Customer Details
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Customer Details
Customer Name:........................................................
Shipping System
Description:........................................................................
..................................
Seasonal Variant: Summer / Winter / All-year / Other
Description of
Payload:.............................................................................
......................................
No. of shipments sent:....................................
No. of failures:...........................................
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Recommendations
Business Development Manager :
...........................................................................................
Recommendation:
...........................................................................................
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Contact Us
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www.laminarmedica.com
Contact details