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Presentation of the label Certicold PHARMA
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?
Sommaire
Pharmaceutical context
1
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 of the health products :
Need for an independent certification of cold chain equipment in Europe
WHY A CERTICOLD LABEL?
The Certicold Pharma Solution
2
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 order of the pharmacists.
Individual certificates issued by an independent body
THE CERTICOLD PHARMA SOLUTION
THE LABELLED products
3
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
Cemafroid
Complete tests in tunnel Cemafroid
Homogeneities according to FDX 15140 (n Text x m Tint) A refrigerated unit model onto 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
LABELING PROCESS
Admissibility
Analysis of the technic file
Audit
Audit system quality of the
factory
Tests
Check Recorders
Homogeneity / Mapping
Isothermal condition - Régulation
Thermostatic 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 onto a body of reference
Analysis of the technic file of the
qualification demand
THE LABELLED PRODUCTS THE VEHICLES OF TRANSPORT OF HEALTH PRODUCTS
Cemafroid
Mechanical strength
Efficiency of closing and opening 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
Performance guaranteed by:
Audit
Type tests of reference products Testings
Annual audits of production
Qualification Verification tests for announced characteristics
NF S 99 700
THE LABELLED PRODUCTS ISOTHERMAL OR REFRIGERANT PACKAGING
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
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
Other equipment related to the cold chain is being studied :
THE LABELLED PRODUCTS OTHER EQUIPMENT
Climatic and thermostatic enclosures
Containers
Thermometers and temperature
recorders
WHY CHOOSE Certicold Pharma
4
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
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
MODE of labelling
5
Cemafroid
Unit verification
by type test
applicant
Application file
Application analysis
Cemafroid
Comittee of labelling
Decision of labelling
Cemafroid
Annual audit
of applicant
Type certificate delivered by Cemafroid
Cemafroid
Anonymous synthesis (Tests+ Audit)
MODE OF LABELLING
Who is issuing the label?
6
The committee of labelling Certicold
WHO IS ISSUING THE LABEL
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?
Ibrahim ZAÏD Engineer account manager - Cemafroid
[email protected] +33 1 49 84 84 92
Visit:
www.certicold.com
CONTACT US
