Tuesday, March 8, 2016

CSR – An equal responsibility of the Micro, Small and Medium Scale Enterprises


Over 8,000 large companies complying to Corporate Social Responsibility (CSR) has been a remarkable policy adoption by the Indian Government. This move has put India in league with countries like Sweden, Mauritius and Norway who have robust policies on CSR for industries. But where India lags behind these countries is that the Companies Act does not successfully bring  CSR into the mainstream. India is a country of SMEs. Schumacher said, “Small is Beautiful”.... We need to make the small beautiful in India too. It is imperative that India works towards making the smaller enterprises CSR compliant. Employing close to 40% of India's workforce and contributing 45% to India's manufacturing output, SMEs play a critical role in generating millions of jobs, especially at the low-skill level. The country's 1.3 million SMEs account for 40% of India's total exports. SMEs have a much wider spread, hence a wider reach across communities. We can extrapolate and comfortably say, that the geographical reach through SMEs is vastly higher than through the larger enterprises.

UNIDO on its website on CSR defines Corporate Social Responsibility as a management concept whereby companies integrate social and environmental concerns in their business operations and interactions with their stakeholders. The SMEs need to realise that CSR is not just about spending money. It is an “attitude”. The excuse of being small will only prevent the SME from becoming world class. SMEs are equally responsible towards making living conditions better for their employees and their families. What SMEs do not realise is that CSR is the only way through which the company can achieve a balance of economic, environmental and social goals. As we move ahead in the 21st century – India can achieve its dreams, and turn its burgeoning young population into an asset only if each company big or small takes on responsibility for social, educational and environmental upliftment at large. This will go a long way in creating harmony between workers and the management, while at the same time addressing the expectations of all stakeholders in business.

The smaller enterprises need to not always spend in rupee terms for CSR. They have to first educate themselves on CSR. The UN through its UNIDO programmes in developing countries has successfully defined a Triple Bottom Line (TBL) Approach, which has proven to be a successful tool for SMEs in the developing countries to assist them in meeting social and environmental standards without compromising their competitiveness. The TBL approach is used as a framework for measuring and reporting corporate performance against economic, social and environmental performance. SMEs need to realise that profit alone will not drive them to become successful. They have to successfully integrate environment and society with economics.

UNIDO continues to articulate very appropriately that “A properly implemented CSR concept can bring along a variety of competitive advantages, such as enhanced access to capital and markets, increased sales and profits, operational cost savings, improved productivity and quality, efficient human resource base, improved brand image and reputation, enhanced customer loyalty, better decision making and risk management processes”.

At a whopping approximately 48 million, India has the second largest number of SMEs in the world, after China. While SMEs  are the predominant form of enterprise in India, it is essential that they also comply to CSR standards and are reportable to the government. The government should consider modifying the Companies Act to ensure atleast a reporting by SMEs on what they have done. This will force them to begin to think on those lines. Forcing, however undemocratic it may sound, is often a tool to initiate and change thought processes. CSR could for beginning be within their organisation – More often than not, SMEs tend to ignore the environment within the company itself. They could even look at motivating and training employees on health, sanitation, skill development, environment  - these would change the immediate environment and benefit their families which in turn benefits the company.
CSR initiatives will begin to result in higher motivation and loyalty amongst employees. This in turn will lead to better production efficiencies, lower employee turnover, and eventually lower costs for companies. Very soon, organisations will see an increased sales turnover due to the competitive advantage derived from a good CSR policy.
Compliance to CSR will ensure that the bulk of SMEs undertake the following to help produce quality products and derive customer satisfaction, thereby improving the overall environmental and social surrounding of each one of them:

It is a no brainer that in India SMEs have frequently abdicated their environmental and societal responsibilities. This statement in no way implies that large organisations have become sustainable and are responsible. However, it will be fair to say that more and more large organisations have taken or are taking steps to reduce their environmental impact and in the process giving back to society, which is the very reason for their existence.Large corporations have significant impact on society and environment. They are concernced about their brand reputation too. Therefore, they invest in CSR. However, it is important to appreciate that social and environmental impacts are interconnected. The two are related and have to be treated as one by everyone, whether an individual, small enterprise or large enterprise. CSR has to evolve into ISR – Individual Social Responsibility  -  eventually for India to become developed. Hence, it is imperative that SMEs take on this responsibility. It is the government’s responsibility to enable such a revolution, by bringing in the SMEs into the CSR act in a careful and responsible manner. The rules have to be enablers and not irritants for the SMEs. 
To create the sweeping change in education, environment and society that India needs, the returns from focussing on large organisations are diminishing with time. The focus has to shift to enabling SMEs to make an impact on the society and environment. The changes they can bring about, as they have done in manufacturing and contribution to the GDP, in turning India into a developed country through making an impact within their organisation and their immediate neighbourhood is enormous.
This, in no way is to imply that large organisations have become ‘sustainable’, or cannot do much to reduce their environmental or societal impacts. However, it is fair to say that a number of large companies have progressively undertaken steps and measures to improve their social and environmental performance
It is also well known that the large organisations, being forced to disclose their wider sustainability impacts, have increasingly passed on the burden to the SMEs which form their supply chain. The significant environmental and social impacts of large organisations are hidden in their supply chains! This is because of increasing cost competitiveness. So, the government and auditors really need to get to the root of the problem. India along with other developing countries is known for unsustainable practices of suppliers of raw materials (e.g. in electronics manufacturing, electroplating, dyeing or polymer recycling) or the unethical labour practices of production which is outsourced (e.g. in retail and clothing) – These companies do not garner the same scrutiny as their large customers.
With a changing global economic landscape and the rising aspirations of the middle class in India, it is high time, SMEs begin to change themselves and factor in an attitudinal change towards the society and environment and do their bit in the progressive change required to turn India to a better place in the near future. SMEs should remember, if the society and environment around them fails, businesses will fail too. They should also consider CSR as minimising negative impact and creating positive impact in what they do every day of the week. If they begin documenting this, CSR will happen not just automatically, but within their existing resources!

Use of Phase Change Materials (PCMs) in temperature controlled Transportation and storage of Thermo labile Medicines and other products

Sasidharan S Menon **
Subject Matter Expert (SME) – Design & Evaluation
Controlled Environment for Contamination Control

Today, the Indian pharmaceutical industry is valued at $ 22 billion with experts projecting the market to grow at a CAGR of eight per cent during 2010-14, according to the Indian Drug Manufacturers’ Association (IDMA). With this, the exports have also grown. In India, from North to South and West to East transportation and storage of thermo labile products poses great challenges due to variation in climatic conditions. This problem is exacerbated by frequent power outages in many parts of the country. International transportation also throws up similar challenges.  Hence, the cold chain segment is of critical importance as the medicinal products being transported have the likelihood of getting damaged with excessive heat or freezing during shipment and storage resulting in reduced therapeutic efficacy. The cold chain market in India is set to cross USD $ 11 Billion by 2017, with an anticipated growth rate of CAGR 28%. The demand for cold chain logistics especially in the pharmaceutical industry has been growing day by day. This holds a substantial monetary value for the Indian cold chain industry. There is a growing emphasis on developing the pharmaceutical supply chain to maintain the quality and integrity of sensitive goods via the use of cost effective technologies and measures.
Objective
There is a growing need for awareness in this market and objective of this article is to introduce Phase Change Materials (PCMs) - an innovative, efficient and cost effective way of transporting temperature-sensitive pharmaceutical products  and how it can bridge the gap between the regulatory policies & guidelines and the need of the consumer concerning product safety.

Challenges in temperature sensitive drugs, vaccines, clinical sample transportation
Healthcare manufacturers need to safeguard their products and offer evidence of complying to maintain a certain temperature range throughout the movement of goods. Biopharmaceuticals and vaccines contribute to a majority of shipments of temperature-sensitive pharmaceuticals, which are typically high in monetary value and have low product volume. With the surge in mail order shipments, increasing scrutiny by regulatory agencies and the desire to lower costs , the need to develop an effective and reliable cold chain management protocol has become a necessity of utmost importance.
Different Products require different temperatures
One of the main driving factors behind the increased temperature control requirements is the simple question whether temperature sensitive products that requires controlled storage conditions need be shipped under the same temperature conditions. Here, the term “temperature sensitive” needs some clarification. A particular product may suffer degradation if it is heated to +100°C, for example, but is stable otherwise. The likelihood of it being exposed to these conditions in transit between sites is effectively zero while another product may be affected by any temperatures outside +15°C to +25°C conditions. Both of these products will have storage conditions of +15°C to +25°C but it does not make sense to transport these with the same level of temperature control. Regulators hint that necessary actions have to be taken during storage & transportation to ensure product integrity and patient safety (World Health Organization, 2003). It hence becomes imperative to choose packaging and storage solutions as per regulatory requirements with stringent temperature monitoring during the products’ life cycle.





Operating Temperature °C
Application
-30°C to -20°C
Fresh Frozen Plasma
-20°C to -23°C
Blood serum, proteins, Plasmids, DNA, RNA, Anti Sera samples
-5°C -10°C
Tissues on slides
2°C - 8°C
Vaccines, Insulin, Blood Products.
20°C- 24 °C
Blood platelets, Cancer testing drugs, Freeze-Dried or Lyophilized Tissues
Source:
1.      1. Standards Australia on behalf of Committee HT/10. AS 3864-1997 Medical refrigeration equipment - For the storage of blood and blood products. Standards Australia. NSW, 1997.
2.      American Association of Blood Banks. Technical Manual 16th edition. AABB Press. Bethesda, 2008.

Loss of product efficacy

The term cold chain in the pharmaceutical industry applies to certain pharmaceuticals that require the maintenance of a specified temperature range in order to retain their therapeutic effectiveness. The essential temperature range must be adhered to throughout all phases of these drug products’ lifecycle, from the time they are manufactured until the time they are administered to patients (Weir & Hatch, 2004). Since temperature is one of the most important parameters to control during drug transportation, regulatory agencies have published guidelines on cold chain management. A disruption in the cold chain can cause temperature abuse and fluctuations such as cycles of freezing and then thawing, which can significantly weaken or even destroy the potency of certain immunizations (Edstam JS, 2004). Between 75% and 100% of vaccine shipments are accidently exposed to freezing temperatures due to breaks in the cold chain (Matthias, Robertson, Garrison, Newland, & Nelson, 2007).The conventional methods to ship temperature sensitive products use dry ice, water-based gels, and bottles containing freezing liquid. However, these materials can store at only two temperatures ie, 0°C or -80°C. Due to the small amount of pharmaceutical mass, the product quickly reaches the freezing temperatures, potentially causing irreversible damage and reduction in potency. The small heat capacity makes the pharmaceutical products susceptible to rapidly reaching equilibrium temperature with the frozen gel packs (Figure 1). 



Also, as per CDSCO guidelines, special care should be taken while using Dry Ice as the extreme low temperature causes other problems such as shrinkage of the rubber stopper in vials, degradation of the air-quality in the container (Central Drugs Standard Control Organization).
Hence, the need for a technology that can be customized to maintain constant temperatures as per product specifications and the advent of Phase Change Materials (PCMs) minimizing the risk of over freezing due to lesser payloads or limitations in maintaining precise temperature ranges. The figure 2 below illustrates the performance of a minus 23 PCM over a duration of 48 hours subjected to varying ambient temperatures.

What is PCM
Water is a natural form of Phase Change Material (PCM) and most temperature control packaging use water by utilizing its high thermal energy storage capacity during its change of phase from liquid to solid or vice versa. The properties that make water an ideal material for storage & transport of materials for applications requiring temperature maintenance in the range of -2°C to 4°C are as follows,
·         Consistent, repeatable, reliable phase change material temperature of 0° C.
·         High latent heat of fusion.
·         Non-Toxic.
·         Easily packaged into pouches or bottles.
·         Inexpensive and easily Available.
A good phase Change Material should mimic these properties but change phase at different temperatures.
A Phase Change Material (PCM) has the ability to store and release large amounts of heat/energy while maintaining a constant temperature as shown in figure 3. PCM’s have tremendous potential to fulfill the growing need of energy for cooling and heating applications across various industries. 

Figure 3
Application of PCM
Phase Change Materials fall under the sub category of energy exchanging smart materials. Energy exchanging smart materials is defined as those materials that are able to store latent and sensible energy in the form of light, heat, electricity or hydrogen and exhibit reversibility. These are also called as “passive” cooling materials as these work without requiring any moving parts or complicated moving components and avoids the requirement of expensive retrofits or professional installation. PCMs can be placed among the products in HDPE bottles or HDPE pouches and reused for more than 3000 cycles which translates to over 10 years of life before losing its efficacy by 2-3%. Shown below in figure 4 are typical pharmaceutical packaging boxes with different PCM encapsulations.

These packages can maintain temperatures for up to 72 hours which takes care of major challenges of long transit period in air shipments. From a carriers’ perspectives there are three major aspects in moving temperature-sensitive cargo which are warehouse management, loading and flight, which in addition to road transport and other exigencies would be around 48hrs - 60hrs to reach the destination from the point of origin. We are looking at a new technology which got great potential to address product quality and patient safety.
Other Applications

PCM has its application across various industries where there is a need for temperature control and regulation. Example of its application in other industries is summarized below
1.      Cold Chain Industry – PCMs have been proven to be very useful in cold chain industry. The major applications are to maintain temperatures during power failures. Major deep freezer manufacturers have started using phase change materials in their freezer to avoid the spoilage of products during power cut-offs, which is a major problem in India. Many FMCG companies in the dairy industry have started fast adopting phase change materials for last mile distribution into rural areas.















                                 PCM integrated into the end product – Deep freezers at the retail


2.      Building HVAC - PCM based thermal energy storage systems help in reducing capital costs, operating cost and increase efficiency by utilizing off peak electricity during the night hours. PCMs help store this energy during the off peak hours in large insulated tanks, which can be harnessed during the day time for serving the cooling needs of the building. This

3.      Solar Applications- PCMs are being used to store the solar energy in the form of thermal energy which can be used in the absence of sunlight. This enables the solar based systems to work at night without use of external sources of heat/electricity.




PCM application to store Solar energy

4.      Temperature-controlled clothing- PCMs can be incorporated with fabrics in various ways and can be used to provide comfortable temperature even in extreme temperature conditions.

Many more possibilities are yet to be exploited with PCMs extending its application into retail products, home appliances, automobiles etc.

Works Cited

Central Drugs Standard Control Organization. (n.d.). Guideline on Good Distribution practices for biological products.
Edstam JS, D. (2004). Exposure of hepatitis B vaccine to freezing temperatures during transport to rural health centers in Mongolia. Prev.Med, 384-388.
Matthias, D., Robertson, J., Garrison, M., Newland, S., & Nelson, C. (2007). Freezing temperature in the vaccine cold chain: Asystematic literature review. Vaccine 25, 3980-3986.
Weir, E., & Hatch, K. (2004). Preventing Cold Chain failure. Canadian Medical Association journal, 9.
World Health Organization. (2003). Guide to Good Storage practices for pharmaceuticals. WHO technical report series.
Datasheets/ technical Info - Pluss Polymers (P) Ltd., Gurgaon, India
**Mr Sasidharan S Menon, an Electrical Engineer by profession, is in the field of clean rooms and controlled environments for Pharma and Healthcare sectors since 1982 and can be contacted at  contact@sasidharanmenon.com





SavE® Phase Change Materials – Smart Materials for smart cities

Abstract
Thermal energy storage (TES) is an often unrecognized but important component of the developing market for energy storage systems. Most often used to provide cooling capacity for commercial buildings, TES systems are also increasingly seen as an effective means of shifting electricity use from daytime peak periods into less expensive periods of the day or at night, saving money and increasing overall system efficiency. Globally, TES is expected to grow substantially through 2020, with worldwide revenues of $3.6 billion and added capacity of 3,824 MW in that year. (Pike Research analysis). Newer forms of TES using different temperature phase change materials (PCM) and advancement in designs to increase the efficiency of storage is becoming the trend. This article attempts to discuss the application of PCMs in building material and its benefits.
What is a PCM
Phase Change Materials falling under the broad category of smart materials are essentially chemicals which in normal state could be in solid, liquid or semi - solid or waxy state. These chemicals are engineered to change their form or phase at specific temperatures. Now the question is what is special about phase change materials and its role in thermal energy storage. These chemicals as they change their phase they absorb and store the energy. Once the entire phase transformation has happened, this chemical is now capable of providing back the very same temperature back until all of its energy is released.
We could draw an analogy with water to better understand PCMs. Water is a natural form of PCM and most temperature control packaging use water by utilizing its high thermal energy storage capacity during its change of phase from liquid to solid or vice versa. The properties that make water an ideal material for storage & transport of materials for applications requiring temperature maintenance in the range of -2°C to 4°C are as follows,
·         Consistent, repeatable, reliable phase change material temperature of 0° C.
·         High latent heat of fusion.
·         Non-Toxic.
·         Easily packaged into pouches or bottles.
·         Inexpensive and easily Available.
A good phase Change Material should mimic these properties but change phase at different temperatures. It has the ability to store and release large amounts of heat/energy while maintaining a constant temperature as shown in figure 1.

  Application of PCM
To simply understand the possibilities with PCM we must understand the three main functions it provides. One can say it is three products in one; A battery, A passive heating or cooling unit and a temperature regulator.
To take advantage of the above function false ceiling tile using advanced savE® PCMs can be used. The functions and looks of a PCM based tile is close to any other false ceiling tile. In addition these would save energy cost of the building by reducing the HVAC load and providing other benefits which are elaborated further. The below figure 2 illustrates a model of the false ceiling tile.

 *
Benefits of incorporating PCM in the false ceiling tile
Thermal Inertial
Thermal inertia is a property of buildings that resists the fluctuation of building environment with fluctuations in the outside ambience the building is exposed to. Thermal inertia is directly correlated to the building material’s specific heat capacity (in the temperature range of function) and the amount of material (mass) incorporated in the building design. The figure 3 illustrates the fluctuation in temperature outside of the building and corresponding fluctuation inside the building which is narrower due to PCM.



HVAC load

Modern day buildings aim to be sleeker and lighter; however continue to use conventional building materials. As a result, these buildings have lesser thermal inertia, and consequently, major loads of maintaining thermal comfort within the building fall on the HVAC systems. Approximately 20-25% of the HVAC load can be brought down simply by reducing the temperature fluctuations.

Customization

PCMs can be tailored to be most effective depending on the different region and varying air-conditioning requirements. PCMs selected such that they melt or freeze at a specific temperature, absorbing or releasing energy at that temperature in the form of latent enthalpy of the material. By this virtue, phase change materials have more energy storage capacity at a given temperature than the heat storage capacity of any other material on that temperature.

Due to this property, PCMs can increase the overall specific heat density of building materials, in turn increasing their thermal inertia if the application can be extended even to the external envelope of the building.. This can be used to save immense amount of energy as peak temperatures in the climate can be resisted by the building. In fact, in a recent study, it was shown that 5 mm PCM can be used to replace the thermal mass of 50 cm of concrete. Thus lightweight buildings can be constructed without compromising their thermal inertia.


Durability and Sturdiness - Form Stable PCM

Encapsulating and containing PCM from leakages during the phase change can be quite a challenge, when incorporating in building materials. Granulated solid particles of PCM may be mixed in concrete or paint before using in construction; however, these can ooze out during melting and this can affect the structural integrity of the building as well as performance of the PCM. To tackle this problem, form stable PCMs are available specially designed for the application in construction and building materials. The advantage is that physically these remain sturdy and retain their shape even during phase change making it compatible to be incorporated into buildings with ease.

Smart materials such as PCMs in the field of chemicals have a huge potential to add value and contribute to energy efficiency in buildings pushing the bar a level up aiming for smarter cities!