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Presentation of the label Certicold PHARMA Sommaire 1. - - PowerPoint PPT Presentation
Presentation of the label Certicold PHARMA Sommaire 1. - - PowerPoint PPT Presentation
Presentation of the label Certicold PHARMA Sommaire 1. Pharmaceutical context 2. The Certicold Pharma Solution 3. The labelled products 4. Why choose Certicold Pharma? 5. Mode of labelling 6. Who is issuing the label? 1
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Pharmaceutical
context
1
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But
Obligation of results Need to choose appropriate means to achieve results; Need to demonstrate that these means are adapted …
Absence of public specifications, independent label and third party device. Regulations strengthened for the preservation of the temperatures
- f the health products :
Need for an independent certification of cold chain equipment in Europe
WHY A CERTICOLD LABEL?
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The Certicold Pharma
Solution
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Managed by an independent committee of labelling For European equipment in the cold chain of health products, Created by professionals for professionals.. College of Healthcare Professionals College of Equipment Manufacturers; College of Independent Experts; College of Administrations and Supervisory Authorities. A European conformity label A conformity with the GDP and with the recommendations of the
- rder of the pharmacists.
Individual certificates issued by an independent body
THE CERTICOLD PHARMA SOLUTION
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THE LABELLED
products
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Today the label covers 2 types of equipment: The vehicles of transport of health products Isothermal or refrigerant packaging solutions for health products
THE LABELLED PRODUCTS
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Cemafroid
Complete tests in tunnel Cemafroid Homogeneities according to FDX 15140 (n Text x m Tint) A
refrigerated unit model
- nto a body of reference
PREREQUISITE FOR A CERTIFICATION DEMAND
Reference unit
S Reference
body
L Reference
Body
THE LABELLED PRODUCTS
THE VEHICLES OF TRANSPORT OF HEALTH PRODUCTS
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LABELING PROCESS
Admissibility
Analysis of the technic file
Audit
Audit system quality of the factory
Tests
Check Recorders Homogeneity / Mapping Isothermal condition - Régulation
Thermostat ic tunnel
NF EN 13486 FDX 15140 Tests ATP Manufacturer Equipment manufacturer
Cemafroid
Complete tests in tunnel Cemafroid Homogeneities according to FDX 15140 (n Text x m Tint) A
refrigerated unit model
- nto a body of reference
Analysis of the technic file of the qualification demand
THE LABELLED PRODUCTS
THE VEHICLES OF TRANSPORT OF HEALTH PRODUCTS
Cemafroid
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Mechanical
strength
Efficiency of
closing and
- pening systems
Maintaining
temperatures
+2°C/+8°C +15°C/+25°C +2°C/+6°C +20°C/+24°C < -20°C
Thermal requirements Mechanical requirements Technical requirements
Insulation
control
Tested
according to representative seasonal variations Quality Assurance Requirements
THE LABELLED PRODUCTS
ISOTHERMAL OR REFRIGERANT PACKAGING
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Performance guaranteed by:
Audit
Type tests
- f reference products
Testings
Annual audits
- f production
Qualification
Verification tests for announced characteristics
NF S 99 700
THE LABELLED PRODUCTS
ISOTHERMAL OR REFRIGERANT PACKAGING
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Qualification according to standard NF S 99 700
Thermal performance Ability of the package to store products within a required temperature range under a predefined temperature profile Verification of:
Qualification
Verification tests for announced characteristics
NF S 99 700
Guarantee a level of safety of the chain of distribution of temperature controlled products.
THE LABELLED PRODUCTS
ISOTHERMAL OR REFRIGERANT PACKAGING
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For maintaining the label of each type of packaging.
A marking of all certified packaging A type certificate renewable every 3 years Periodic verification of conformity
THE LABELLED PRODUCTS
ISOTHERMAL OR REFRIGERANT PACKAGING
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Other equipment related to the cold chain is being studied :
THE LABELLED PRODUCTS
OTHER EQUIPMENT
Climatic and thermostatic enclosures Containers Thermometer s and temperature recorders
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WHY CHOOSE
Certicold Pharma
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WHY CHOOSE CERTICOLD PHARMA?
For equipment incorporating the latest technology
GDP, WHO, ATP, FD X 15140, NF S 99700, marking CE, norms CEN, Afnor or DIN, etc. Latest technical advances Innovation in the control of the cold chain.
For performances validated and corresponding to the regulations and applicable standards
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WHY CHOOSE CERTICOLD PHARMA?
Production: control of the quality management system Products: tests at regular frequencies For the constant quality of the equipment For a conception that meets the expected functionality
Preservation of the current temperatures, Control of energy Mechanical resistance and durability
For a third-party certification
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MODE
- f labelling
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Cemafroid
Unit verification
by type test
applicant
Application file Application analysis
Cemafroid Comittee of labelling
Decision of labelling
Cemafroid
Annual audit
- f applicant
Type certificate delivered by Cemafroid
Cemafroid
Anonymous
synthesis
(Tests+ Audit)
MODE OF LABELLING
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Who
is issuing the label?
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The committee of labelling Certicold
WHO IS ISSUING THE LABEL
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Consult: The detail of the certified characteristics The list of the certified products Visit:
www .certicold.com
CERTICOLD Pharma
HOW TO KNOW IF EQUIPMENT HOLDS THE CERTICOLD LABEL?
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Ibrahim ZAÏD Engineer account manager - Cemafroid ibrahim.zaid@cemafroid.fr +33 1 49 84 84 92 Visit: