Storage and transportation conditions
Such samples should be based on seasonal extremes. Relative humidity: 75 Atmospheric pressure: conditions from eMPTY 700 hPa to transportation 1060 hPa. It does not apply if the transportation device was damaged as the storage result of conditions a storage shock, an and accident, incorrect use, insufficient protection against humidity, plunging into water or a repair not carried out by our after-sales service department. O guarantee your safety, the and design, T manufacturing and conditions distribution of and Compex storage are storage in conformity with storage the conditions requirements of the and European Directive 93/42/CEE. Urrent international standards and (IEM1 2001) require that transportation a warning be given concerning the and application of electrodes to transportation the and thorax (increased risk of cardiac fibrillation). Never dismantle the storage Compex or the charger containing high-voltage parts because of risk of electric discharge. This document builds on other pre-existing international guidance (see List of References). Semen is storage excluded from the scope of this guide. He Compex guarantee comes into, t effect on the date of purchase conditions of the device. Section 11 of the. Alternative means of complying with the intent will be considered with appropriate scientific justification. Temperature excursion - transportation A temperature excursion is a variance outside of the labelled storage and conditions. Output 9V /.4A / 15W Type TR503-02-A-133A03 Input 90-264 VAC /47-63Hz /.5A max. This guidance is not intended to cover every conceivable case. Irective 2002/96/CEE Waste electrical D and storage electronic equipment (weee). Fabricators, packagers/labellers, distributors, importers and wholesalers are additionally responsible for storage the appropriate handling, storage storage and distribution of drugs according.02.015 of the. The responsibility of each party, is to ensure transportation that the required storage and transportation conditions conditions are met through their respective GMP activities. T and the special electrode cable for the m-4 system (goods and labour but does not cover the other cables, the electrodes and the batteries. Temperature is one of the most important parameters to control. Output 9V / 400mA / 6W Type TR1509-06-A-133A03 Input 90-264 VAC / 47-63Hz /.5A max. For requirements regarding cells, tissues and organs (CTO please refer to Health Canada's guidance document entitled ". These include: the ambient temperature and humidity the quality of the storage container the number of times the container is opened and closed. Supersedes: October 17, 2005, date issued: January 28, 2011, date of implementation: April 28, 2011. Every activity in the distribution of drugs should be carried out according to requirements of the. He device is in conformity with the T standard for general safety conditions rules for electromedical devices IEC 60601-1, the standard for electromagnetic compatibility IEC and the standard for special safety rules for nerve and and muscle stimulators storage storage IEC. Our Mandate: To promote good eMPTY nutrition and informed use of drugs, transportation food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system. Patent m-4 : US Patent 6,324,432. Good Manufacturing Practices Guidelines - 2009 Edition (GUI-0001) ". Egal rights are not affected by this. This document is not intended to provide legal advice regarding the interpretation of the Act and or Regulations. By following these BOC guidelines safety will be ensured. Uniform Classification of Accounts and Related Railway Records, April 1998, Canadian Transportation Agency). If this is unavoidable the load should be well insulated and adequate ventilation transportation must be maintained it is preferable to transport dry ice and in vehicles where the driver's cab is isolated and from the load compartment always secure the load. T to the device or any of its eMPTY accessories. These characteristics are stable and do not vary when used under normal conditions. Relative humidity: from 30 to 75 Atmospheric pressure: from 700 hPa to 1060 hPa Do not use in an explosion risk area. In cases where the requirements for blood and blood components for transfusion differ and from what appears in Health Canada's guidance document entitled "Good Manufacturing Practices for Schedule D Drugs, Part 2, Human Blood and Blood Components the latter will take precedence. The information given in this handbook must be strictly observed. Patents pending in the USA, Japan and Europe. C ompex Mdical SA declines all responsibility for damages and consequences resulting from any attempt to open, modify or repair the device or any of its components by a person or a service centre not officially approved by Compex, mdical. Transport, the list below offers suggestions for the safe transportation of dry ice: avoid transporting dry ice in the cab of a truck or the passenger compartment of a car.. Food and Drugs transportation Act, the principles of Good Manufacturing Practices (GMP as well as appropriate storage and transportation practices. Different approaches may be called for as new technologies emerge. The pictogram wheeled bin barred means that the equipment can not be thrown with the household refuse, but that it makes the object of a selective collection. Food and Drug Regulations. He equipment has transportation to be given to a T suitable collection point for the treat- ment. Use conditions Temperature of use: from 0C to 40C Max. M edical and health professionals must refer to local legislation for information related to maintenance. He Compex is a class II device unit T with its own internal electric power, with type BF applied sections. Technical information General points ower supply: nimh rechargeable P battery (nimh) (4,8 V 1200 mA/h). He user must not attempt any repairs. For large 'walk-in' load compartments, the doors should be capable of being opened from the inside always ensure that there eMPTY is adequate ventilation during transportation and before storage entering the load compartment to unload the product always carry a 'Carbon Dioxide. These requirements are in place conditions to maintain the safety, quality and efficacy of the drugs. The better the insulation, the slower the sublimation rate, the longer the quality of the product will be maintained. Hargers: The only chargers used for C recharging the battery bear the following information: Type TR503-02-E-133A03 and Input 90-264 VAC / 47-63Hz /.5A max. The maintenance of the chain of storage and transportation conditions should be supported by written agreements among the distributor, the importer, the wholesaler, and the transportation provider in order to preserve drug safety, quality and efficacy. The guarantee is valid only on presentation of proof of purchase. Lane/Route Profile - A lane/route profile is the temperature data collected on a product - outside of a temperature-protective shipping package - for a sample of the environmental conditions in the transportation routes that are used for shipping. T and an alcohol-based cleaning product, which does not contain any solvents. Normalised symbols mportant: Under some condi- I tions, the effective figure for the stimulation pulses can exceed 10 mA and. Containers, specially designed containers are required for dry ice storage and transport. See the range of different types of containers available. These guidelines apply equally to drugs for human and veterinary conditions use and to clinical conditions trial drugs for human use as required under.05.010 (j) and to samples that are distributed to professionals as per Section 14 of the. Atteries must be disposed of in B accordance with your country's national laws governing the disposal of such items. Storage, many factors can affect the rate at which dry ice sublimes from solid state into gaseous carbon dioxide. Controlled Storage Conditions - Conditions that need to be maintained (for example, humidity, temperature, transportation light) during the time the drug is transported and stored per the manufacturer's labelled storage conditions for the drug product. He guarantee covers the stimulator. Elimination he Directive 2002/96/CEE (weee) T has a first priority, the prevention of waste electrical and electronic equip- ment, and in addition, the re-use, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. Output 9V /.4A / 15W. Drug products must be transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions; potentially impacting the safety, quality and effectiveness of the drug product. Aste electrical and electronic W equipment (weee). Temperature excursions outside of their respective labelled storage conditions, for brief periods, may be acceptable provided stability delivery options data and scientific/technical justification exists demonstrating that product quality is not affected. Output 9V /.4A / 15W Type TR503-02-U-133A03 Input 90-264 VAC / 47-63Hz /.5A max. Food and Drugs Act. It covers all the defects resulting from a problem of quality of the material or from a production error. Environmental controls play a key role in maintaining drug safety, quality and efficacy. Standards he Compex is based directly on T medical technology. Normally, these laws require verifica- tion of certain criteria at regular intervals. F your device seems not to function I as expected, regardless of the situation, contact an official Compex service centre for assistance. The list below offers suggestions for the proper storage of dry ice: always store dry ice in a properly designed container keep the container lid closed when not in use always secure the container lid open before reaching. Maintenance o clean your unit, use a soft duster. Drugs must be stored, and transported according to predetermined conditions (for example, temperature, etc.) as supported by stability data. Special care should be taken when storing and transporting dry ice.. Storage and transportation conditions he Compex contains rechargeable T batteries and so the storage and transportation conditions must not exceed the following figures: Storage and transportation temperature: from -20C to 45C Max. Food and Drugs Act, read together with the definition "unsanitary transportation conditions" in Section 2 of the. Output 9V / 400mA / 6W Type TR1509-06-U-133A03 Input 90-264 VAC / 47-63Hz /.5A max. It is important to use both IgM and NS1-antigen tests to confirm acute dengue particularly under the adverse field conditions, where proper storage and transportation of specimens are missing, which substantially reduce the sensitivity of the RT-PCR for detecting denv RNA. Food and Drugs Act, prohibits any person from: ".packaging or storing for sale any drug under.such conditions or circumstances as might.render a drug injurious to health". He Compex stimulators are contrac-, t tually covered with a guarantee of 2 (two) years: register on our web site: fo (section "Register. Qualified shipping container/package - A package that can repeatedly demonstrate through documented testing, a high degree of assurance that the determined acceptance criteria are met and will maintain the quality of the drug product under such conditions. Guidance Document for Cell, Tissue eMPTY and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation ". The following additional definitions supplement the definitions provided under the Glossary of Terms in the main ". Final and Distribution Point - The final destination where the drug will be used or sold (for example, pharmacy, hospitals, clinics, retail stores, etc). Snap electrode: Patent pending. Distribution and wholesaling form part of the supply chain of drug products. Carrier/ Transportation Provider - A person who is engaged in the transport of goods or passengers by any means of transport under the legislative authority of Parliament. If a regulated party has questions about conditions their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel. Ompex stimulators do not require, c 92 calibration or verification of performance parameters. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. All persons and companies storage including fabricators, packagers/labellers, testers distributors, importers, and wholesalers have the responsibility for ensuring that appropriate storage and transportation conditions are maintained from the point of manufacturing up to the delivery of the drug products to the final distribution point. This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. These guidelines are intended to be applicable to all persons and companies involved in the storage and transportation of drug products. The characteristics are systematically verified and validated for each device manufactured. Output 9V / 400mA / 6W Type TR1509-06-E-133A03 Input 90-264 VAC / 47-63Hz /.5A max. Containers and their corresponding transport pallet are available for purchase from BOC. He "On/Off" switch is a multi- T function key: Functions Symbol N (according to CEI 878) On/Off (2 positions, stable) 01-03 Waiting or preparation for part of the unit 01-06 Stop (switching off) 01-10. Stability Data - Data from the accelerated storage condition stability study and, if appropriate, from the intermediate storage condition stability study can be used to evaluate the effect of short term excursions outside the labelled storage conditions (such as might occur during shipping). By this way, you contribute to the safeguarding of the natural resources and the human health protection. Transportation and storage conditions.
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