By Anupam Chanda, Sun Pharma Laboratories Ltd, 25/05/2015
The cold chain refers to the temperature management of perishable/highly moisture and temperature sensitive products in order to maintain quality and safety from the point of slaughter or harvest/manufacturing location through the distribution chain to the final consumer
Different industries require their raw materials and finished goods to be transported under temperature controlled conditions. This is necessary to preserve the integrity and quality of the overall product The implementation of an effective cold chain solution minimizes loss of texture and flavour to produce and delivers fresh products to the end user both in and out of season
•Increasing regulatory scrutiny. During an inspection you need to be able to answer the usual quality-focused First questions about your cold chain integrity: “How do you know? Can you prove it?” Anyone complaint with GxP who manages any link in the supply chain needs to be prepared for these questions •More biopharmaceutical products coming onto the market all the time. By some estimates, 50% of the entire drug market will be biologics by 2018. These drugs tend Second to be more sensitive to environmental conditions and therefore require more care as they move through the supply chain. You should be aware of this if you handle these types of products •New focus on drugs that must be kept at controlled room temperature (CRT). This is usually defined as 20°C to 25°C with allowable excursion between 15°C and 30° as long as the mean kinetic temperature remains in the Third defined range. (Refer to USP 1079 for more information on CRT). Drugs in this category are typically less sensitive to environmental conditions, but when storage temperatures are defined, it is reasonable to ask if they have actually been maintained properly.
solution providers clamoring for position “temperature management through the Offering different solutions supply chain Temperature data loggers These devices are usually started at the stopped at the end beginning of a shipment, uploaded manually to a PC provide a time history of the transport provide a temperature history of the duration transport duration
There are more complex data loggers that can measure temperature, humidity, shock, vibration, and other parameters. They may have GPS capability and even the possibility of real- time tracking and reporting. Some communicate via RFID to simplify the gathering of information. There are also software solutions available to capture and track all of the information from the data loggers.. There are also packaging providers with a variety of package- based temperature control solutions. Some packaging is completely passive and custom-designed for a specific application. There are also active containers that can heat and/or cool the drug product as necessary. Some active containers are specifically designed to fit the mode of transport, such as airplanes. Some global supply chain solutions. Some are smaller companies that can organize your supply chain for you, using a variety of resources as necessary and complying with all applicable regulations. There are firms that can map your transportation routes and the storage areas. vehicles that travel these routes
CDC Guidelines The Guidelines on for Maintaining The EU Guide to Good Distribution and Managing the Good Manufacturing Practice (GDP) of Practice, Vaccine Cold Medicinal Products Chain WHO Guidelines on the The US Code of international PDA Technical Federal packaging and Report 49 Regulations shipping of vaccines The International US and Committee for European Harmonization Pharmacopoeia (ICH)
Understand your current supply chain. Map it out so that you know where your facility and/or process is in the context of a product’s entire supply chain. Consider where your supply chain is going. Be willing to reach out to solution providers. If your geographic scope is currently limited They may have more expertise in cold chain and you have made your decisions than you and your organization. Seek accordingly, you may have to re-think guidance from the outset to save the trouble everything if your geographic reach of having to fix a broken system later on. expands. Determine whether you need simple solutions (use of discrete data loggers) or more complex solutions Prepare to validate whatever it (GPS-enabled measurements is you decide to implement. with real time reporting Current regulatory scrutiny 24/7). This will require expects a qualified cold chain. consultation with other people in your company and other parties in a product’s supply chain.
The Parenteral Drug •www.pda.org Association Global Cold Chain • www.gcca.org Alliance International Safe •www.ista.org Transit Association International Society for Pharmaceutical Engineering - www.ispe.org
GCCA is an umbrella organization which acts as the platform for communication, networking and education for each link of the cold chain, and is comprised of members from Core Partners Our members represent critical links in the cold chain across N. America and in 65 countries around the world. GCCA members WFLO : World Food are comprised of 345 public refrigerated warehouse (PRW) companies, 1006 facilities, 80 construction companies, 112 Logistics Organization transportation companies and 387 suppliers to the industry. IRTA : International IACSC : International IACSC : International Refrigerated Association for Cold Association for Cold Transportation Storage Construction Storage Construction Association
creation adoption implementation
Vertical Frozen Chilled QSR - -4 to -6 o C Pharmaceutical -22 o C (vaccines) 2 o C to 8 o C Meat & Poultry -20 o C - -- Processed Food -18 o C ----- Ice cream -25 o C ----- Dairy ------ 2 o C to 4 o C Chocolates ------- 16 o C to 18 o C Retail -18 o C to -22 o C -18 o C to -22 o C
Proven track record Risk Domain and technical expertise mitigation strategies Modern & Experienced Trained staff young fleet of technical team reefer vehicles
700 624 600 497 500 INR BILLION 389 400 298 300 228 175 200 134 115 98 100 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 YEARS
Cold chain segments storage 12% transport 88%
currently India has 6300 cold storage facilities unevenly spread across the country. With an installed capacity 30.11 million metric tonnes 1) Organized players contribute only 8 to 10 % of the cold chain industry market, 2) 36% cold storage capacily below 1000 MT 1) 65% of India’s cold chain storage capacity is contributed by the states of UP & West Bengal. 2) As per current capacity only less than 11% of what is produced can be stored.
Selection of right insulated packaging material Proportionate Perfect use of cooling Packaging materials inside Design the primary and secondary pack
Polyurethane, the best •Polyurethane remains unrivaled as an insulation medium. It combines light insulating material weight, low cost and easy fabrication with very low thermal conductivity of 0.025 W/mK. Using polyurethane insulation ensures •Polyurethane is also a flexible material, that products can be kept cooler for easier to process than polystyrene. It can longer with reduced energy inputs and easily be moulded into shapes to suit also that lighter and more compact specific requirements. This means that packaging can be used. All these are key polyurethane can be used to factors in reducing specific cool-chain manufacture custom-designed insulated costs. pharma packaging solutions. •polyurethane is also a material that is easy to recycle, both mechanically and chemically. Examples of polyurethane recycling include rebonded carpet underlay or to create polyols used in automotive components.
Process Flow Diagram •Identify product •Product stability Profile •Transportation process flow consideration •Bulk & Intermediate ,Finished goods, Analytical samples
Generate documents for component specification Design testing Develop OQ Develop PQ protocol protocol
• Implement Distribution chain the process training • Quality Develop system training • Regulatory perspective Auditing distribution • Perform chain monitoring
•Validation is documented Definition of testing that consistently produces a result meeting validation pre-determined specifications. • Qualification is documented testing that demonstrates with a Definition of high degree of assurance that a qualification specific process will meet the pre-determined acceptance criteria .
Drug substance manufacture East coast US Shipment at – Distribution of 80 deg.C to final product to drug product customer at 2- manufacturing 8 deg.C site EU Shipment of Shipment of semi finished semi finished product to product at 2- 8 packaging site deg. C to in US at 2- 8 distribution deg. C center in EU
Each manufacturing step at RT to capture Total processing time at RT is Each steps covered by manufacturing analytical step has an acceptance limit stability data of the product Sum of all manufacturing steps has to be within limit
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