Innovations in cold chain equipment for …
19.04.2017 · 1.2. Evolution of cold chain equipment. When EPI cold chains were established in the 1970s, absorption refrigerators were the only option for sites with no grid electricity . A number of these devices were prequalified and included in the WHO Product Information Sheets (PIS, the prequalification system that preceded PQS).
WHO | World Health Organization
E007: Cold chain accessories; E008: Injection devices for immunization; E010: Waste management equipment; E013: Injection devices for therapeutic purposes WHO PQS Devices Catalogue. The WHO PQS Devices Catalogue includes details of all immunization- related products currently pre-qualifies by WHO for procurement by United Nations agencies, in addition to comprehensive guidance notes to …
Immunization cold chain equipment (CCE) - …
Immunization cold chain equipment (CCE) Everything you need to know about specific WHO PQS-prequalified products including installation and maintenance guides, training resources, brochures, videos, photos, as well as product feedback from TechNet members. Find a product using the search below, or else explore categories of products. Additional resources on cold chain equipment can be …
The vaccine cold chain - WHO
WHO defines a CTC as the on-label use of a WHO-prequalified vaccine out of the traditional +2 °C to +8 °C cold chain for a limited period of time, at temperatures of up to 40 °C, just before administration. Vaccines licensed accordingly can be used in a CTC.
Assessing the Total Cost of Ownership for Cold Chain Equipment
Abbreviations: CCE, cold chain equipment; FAQ, frequently asked question; PQS, Performance, Quality and Safety; TCO, total cost of ownership. A three-step approach to understanding total cost of ownership 1 Compare technologies •General comparisons of hardware and installation, plus recurring operating costs. 2 Compare models •Model-to-model comparisons paired with local assumptions. 3 ...
Premises & Equipment Qualification - Global Cold …
Qualification is an essential part of the temperature sensitive supply chain & quality assurance system to demonstrate that a site, the processes and equipment are suitable for purpose and the intended use. GCCS experts and engineers provide GMP qualifications services for: The premises – Warehouses / Cool rooms & freezers
Cold Chain - Qualification vs. Validation | Pharma …
The nomenclature used for describing testing of cold chain packaging used to demonstrate its performance is somewhat controversial. Here we discuss Qualification and Validation, the two most popular terms used to describe such testing. Validation is documented testing, under highly controlled conditions, that demonstrates that a process consistently produces a result meeting pre-determined ...
WHO Prequalification
Prequalification of immunization equipment and devices WHO prequalifies not only the actual vaccines but also a comprehensive range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery. The Performance, Quality and Safety (PQS) scheme for the prequalification of equipment and devices for immunization was introduced in 2006 and became ...
Temperature qualification, humidity qualification …
Temperature Qualification is a detailed study, which is involving many tests and designed to evaluate various equipment. Qualification study will be carried out in various assets such as warehouses, reefer trucks, cold rooms, refrigerators, Passive or Active boxes etc. which are mainly for transporting and storage of pharmaceutical products, medicines, foods etc.
PRE-QUALIFICATION NOTICE LOT A: GOODS
equipment maintenance UNDP/A/017 Laboratory supplies: laboratory consumables, chemicals and related sundries, laboratory equipment, repair and calibration UNDP/A/018 Clinic furniture, BMI Equipment(weighing and measuring scales), clothing and Linen, staff Uniforms, COLD CHAIN EQUIPMENT, IT Equipment, Medical OUTREACH Supplies e.g. Tents, Logos etc.
Medical Cold Chain Equipment - intellectualventures.com
Medical Cold Chain Equipment Looking to the Future. Cold Chain Equipment (CCE) status Percent of facilities, 2014 estimated 100% 20% 42% 23% 14% 2% Unequipped facilities targeted for CCE Poor-performing technology (absorption refrigerators, solar with battery, domestic refrigerators) Outdated but adequate technology (absorption refrigerators, solar with battery, domestic refrigerators) Non ...
Cold Chain 101 The First Steps - Parenteral Drug Association
Cold Chain Components . 1. Stability Data (Technical Documents) •Excursion Budget 2. Shipping System PQ (IQ and / or OQ) •Every shipment •Sample 3. Equipment •Thermometers •Refrigeration units •Air Conditioners •Temperature Monitoring System •Independant •Alarmed . V.01
WHO Prequalification: Built to Last in a Fast-Changing World
• Strengthen PMS for Immunization equipment, Cold Chain Equipment and Vector Control Products • Pipeline scanning and parallel policy developing and determination of eligibility for Prequalification. How can we best meet those challenges? In partnership Copenhagen, Denmark 2 –5 December 2018 12
WHO | World Health Organization
The following resource documents can be accessed to support cold chain equipment (CCE) management processes, as well as enhance knowledge and understanding of CCE and their functioning E001 Cold rooms, freezer rooms and related equipment
Equipping the Supply Chain Update on the WHO PQS ...
1.E001 –Cold Rooms and Freezer Rooms 2.E002 –Transport 3.E003 –Refrigerators and Freezers 4.E004 –Cold boxes and vaccine carriers 5.E005 –Coolant packs 6.E006 - Temperature monitoring devices 7.E007 - Cold chain accessories 8.E008 - Injection devices for immunization 9.E010 - Waste management equipment
Qualification of temperature-controlled storage areas
equipment or installation is likely to perform as intended in the operating environment in which it will be used. This is operational qualification. Stage 3: Carry out a final stage of documented testing to establish with a high degree of assurance that the equipment or installation, together with all associated systems, does indeed perform as intended under routine operating conditions. This ...
Cold Chain Validation | FDA | EU | WHO | FLCV | …
Cold Chain Validation Package level-1 (Issue 3) $575.00 12000396. This is the common document package that is sent out with all our Cold Chain Validation Packages. It contains five documents that make up the advertised document package. No matter what your validation requirements are these documents will guide you through the task. No matter ...
GMP aspects of cold chain management for pharmaceutical ...
6 Cold chain management for pharmaceutical products • Qualification1) of storage equipment (eg freezer) • Calibration of sensors (pre/post validation) • Temperature distribution (empty/loaded) • Critical alarm functions tested • Predefined acceptance criteria • Written and preapproved protocols 1) Qualification: proving and documenting that equipment or ancillary systems are
Einkäuferinformationen
China Cold Roll-forming Steel Association (CCRSA) is an national organization in tube, pipe, and other cold roll-forming products industry in China. Founded in 1985 and with more than 160 members currently, CCRSA has the great influence upon the industry. The production capacity of corporation members of CCRSA exceeds more than 15 million tons in more than 2,000 specifications.