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