Reliable and efficient disinfection of cleanrooms

Cleanroom disinfection is a routine procedure in industries dependent on microbiologically clean areas for production and R&D. This would include companies in the pharmaceutical, biotech, cosmetic, and other microbiology industries.

Surface disinfection is an integral part of this process, with a diverse range of techniques being used. Standard techniques used include:

• Wiping disinfection
• Fogging
• Thermal processes
• Gassing and UV light.

The techniques favoured by different

companies can be internally elected, based on effort and efficiency, or externally imposed, by regulatory bodies.

Regulatory standards for microbiological cleanliness set requirements for regular, certified bio-decontamination of specific areas. A company may have one or several areas that require regular disinfection in order to provide a microbiologically clean environment.

The use of a dry fog system based on hydrogen peroxide and peracetic acid offers a reliable, highly effective (6 logreduction) and environmental friendly solution.

What is Dry Fog?

As its name indicates, Dry Fog is a biocide aerosol which is released into the air’ Small super-lightweight dry fog particlesdistribute evenly across a large area.

Dry fog is defined as an aerosol particle which is less then 10µm big. It is also referred to as ‘Ultra Fine Atomization’.

The dry fog system generates aerosols of the size of 7.5µm. Due to the light-weight drifting nature of the particle, top, side and bottom surfaces will be covered.

What is the advantage?

Comprehensive bio-decontamination: Dry fog disperses better then wet fog. This leads to considerably more surface contact and even difficult to reach surfaces will be decontaminated.

Portability: The Dry Fog is easy to assemble

Safety: As a ‘dry’ material, there is less chance of reaction to electronic components that with traditional wet-fog products. There is no need to cover or to remove electronic components.

Durability: The aerosol particles do not collapse and bind when coming into contact with other particles or the target surface. As a result there is little or no condensation, resulting in a larger surface area being evenly covered.

The Minncare Dry Fog system

The Minncare dry fog system consists of a dry fog machine and a biocide. The biocide is a stable mixture of hydrogen peroxide and peracetic acid, to which water is added. The dry fog machine relies on 5 bar (or higher) compressed and clean air or a nitrogen connection.

After fogging a cleanroom, the residuals that can remain are oxygen and acetic acid.

Procedure

With all four nozzles operating it is possible to disinfect up to 1000 m³ from one point. Several inter-connecting rooms can even be decontaminated from just one position. The biocide will be diluted with either de-ionised water or water for injection. The dilution factor depends on the relative humidity and room temperature.

The HVAC needs to be off during the fogging phase otherwise the fog can’t disperse evenly.

The optimal relative humidity should be prior to fogging less then 60% and during the fogging phase it shouldn’t exceed 80 –85%. Best sporicidal activity is between 70% – 80%. The dry fog systems allows to disinfectant rooms from 20m³ to 1,000m³.

The mini Dry Fog is for smaller environments useful like laminar flows, biohazard cabinets from 1m³ to 20m³.

In the example was a 6log reduction in spore B. Stearothermophylus ATCC 7953 achieved.

What about residuals?
In a worst case scenario the maximum of acetic acid would be <0,00002ml per m².

Whilst some pharmaceutical companies still use formaldehyde which is very toxic and highly corrosive compared to Minncare, which is biodegradable.

Budget and Environmentally friendly

Compared to normal surface disinfection, DryFog has a huge cost saving potential. For 1 m³ of room only 1,5 ml of concentrate

is required. If one combines it with reduced downtime and high efficiency it offers a reliable solution.

Investing in stocks that pay high dividends is an effective way for the conservative investor whose concern is mainly with the preservation of capital. When investing for a high dividend yield, the most important consideration for the investor is the sustainability of such dividends. Hence research into the underlying dividend payer is crucial.

I should make it clear that I’m not recommending any of the stocks I write about. Any investor who is contemplating investing for a high dividend should use these articles a base from which to do further research and in depth analysis.

The largest drug companies as a group currently sit with large amounts of cash and recurring cash flow streams, which over the past few years have resulted in high dividends to stockholders.

One such company is Sanofi-Aventis (SNY), a French based pharma giant with a market capitalization of just under $100 billion. The company is the the world’s fourth-largest pharmaceutical firm by prescription sales.

Sanofi-Aventis engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the firm also develops over-the-counter medication. Sanofi-Aventis covers 7 major therapeutic areas: cardiovascular, central nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines (it is the world’s largest producer vaccines). The company’s biggest selling drug is Lovenox, and it also produces Ambien which hopefully you won’t require while reading this article.

At a price of $36.50 the company is sitting on a dividend yield of 4.43% (it paid out $1.63 per share in 2009). The company is cash flush with almost $7 billion in cash on the balance sheet which represents about 20% of current assets. Over the past five years, the company has generated on average about $10 billion in cash from operations. Total dividends paid over the same period average to around $3.1 billion per year, so one can see how this cash cow’s dividend from a historical perspective has been strong.

However dividend investors are concerned with the future viability and sustainability of dividends. Pharmaceutical companies are going to come under pressure when patents on many of their leading drugs expire, opening them up to competition from generic manufacturers which naturally erode margins and lower profits and cash flows. Sanofi is not excluded from this problem.

In saying that, given the large annuity revenue streams these firms have built and the tremendous amounts of cash they throw off, the Sanofi model still present significant barriers to entry from competition. Research shows that the dividend is likely to remain at current yields for the considerable future. While pharma giants are not replacing revenue through new products and research as quickly as it is being eroded through generic competition, the deal between Pfizer (PFE) and Wyeth shows just how easy it is to pick up an entirely new drug pipeline when you’re sitting on copious amounts of cash.

Sanofi is likely to be able to generate more than sufficient cash flow to produce strong dividends to shareholders, and thus the yield is probably relatively secure for the income-seeking investor.

Sanofi trades on a PE ratio of 13.65 times and a price to book of 1.5 times, both of which are conservative by industry standards. Debt is also much lower than peers and return on equity is much higher, albeit at only 11%.

Devices affected, date of last manufacture in the US and manufacturers affected are:

• Tilade Inhaler (nedocromil) – June 14, 2010 – King Pharmaceuticals
• Alupent Inhalation Aerosol (metaproterenol) -June 14, 2010 -Boehringer Ingelheim Pharmaceuticals
• Azmacort Inhalation Aerosol (triamcinolone) – Dec. 31, 2010 – Abbott Laboratories
• Intal Inhaler (cromolyn) – Dec. 31, 2010 – King Pharmaceuticals
• Aerobid Inhaler System (flunisolide)- June 30, 2011 – Forest Laboratories
• Combivent Inhalation Aerosol (albuterol and ipratropium in combination) -Dec. 31, 2013 – Boehringer Ingelheim Pharmaceuticals
• Maxair Autohaler (pirbuterol) – Dec. 31, 2013 – Graceway Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun’s harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

“During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA’s Center for Drug Evaluation and Research. “We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.”

The CFC phase out is part of an international agreement to ban substances that deplete the Earth’s ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

In January, Rep. Edward J. Markey, chairman of the House Energy and Commerce Subcommittee on Energy and the Environment, sent a letter to the FDA requesting information about the status of FDA’s ongoing review of triclosan in consumer products.

In responding to the Chairman’s letter, FDA explained that, in light of animal studies raising questions about triclosan’s safety, the agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. The FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

For some consumer products, there is clear evidence that triclosan provides a benefit. For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

Daniel O’Day, Chief Operating Officer Roche Diagnostics, said: “Diabetes has become a real epidemic that affects more than 285 million people worldwide. Roche Diabetes Care, a global leader in blood glucose monitoring and insulin delivery systems, is committed to improving the quality of life for people with diabetes. With this acquisition we will broaden our portfolio of innovative insulin delivery technologies and strengthen our position as a leading player in the diabetes care business”.

The new Medingo Ltd. micro pump insulin delivery system consists of two parts: a semi-disposable insulin dispensing patch and a remote control, which allows for discreet personalised insulin delivery. It provides the functions of a conventional insulin pump alongside with all advantages of the innovative tubeless patch pump technology. Features like the ability to administer an insulin bolus directly from the patch pump without a remote control, as well as the option to temporarily disconnect the pump from – and later reconnect it to – the patch securing it to the skin, offer enhanced convenience to insulin pump users.

The Medingo Ltd. patch pump is not yet marketed. In a next step, production capacities will be scaled-up to prepare for global launch which is expected by 2012.

The acquisition will strengthen Roche Diabetes Care’s position in the fast growing segment of insulin delivery systems. In 2009, the insulin delivery system global market was estimated at CHF 1.6 billion. While the whole market is growing rapidly, the expectations for the growth of the patch pump segment are even higher.

Zvika Slovin, Co-CEO of Elron Electronic Industries Ltd., said: “The fate of diabetes patients has been at the center of the Medingo Ltd. from the foundation of the company. Therefore, Medingo Ltd. as well as its shareholders are very pleased to have found a very strong and potent partner in Roche to ensure success of Medingo Ltd.’s products and research and development”.

Roche Diabetes Care develops and commercializes innovative solutions in the field of insulin pumps combining blood glucose monitoring, information management and personalized insulin delivery As an example of this new class of integrated product solutions the company recently has launched the Accu-Chek Combo system in Europe with great market success, allowing for enhanced efficiency and convenience in managing insulin pump therapy.

“The integration of Medingo Ltd. is a perfect fit to our existing diabetes management product portfolio”, stated Burkhard G. Piper, Head Roche Diabetes Care. “Offering an innovative micro patch pump will bring our competence in the area of integrated insulin delivery systems to a broader range of people with diabetes on insulin therapy, providing a greater choice to meet the different individual needs”.

As part of Roche Diabetes Care, Medingo Ltd. will continue to further develop and produce the insulin patch pump system which will be integrated into Roche Diabetes Care’s insulin delivery portfolio. “As we share the same vision of providing integrated diabetes management solutions for insulin pump users, Roche to us was the partner of choice to bring our technology to life. The integration into the Roche Diabetes Care business unit offers the opportunity to broadly market our innovative patch pump system with a leading global company, which brings its knowledge and strong market expertise into play”, said David Vidan, General Manager Medingo Ltd..

This will increase the supply and visibility of Vitabiotics products to consumers.

“We chose Clicks due to their level of experience and large number of stores countrywide. Clicks will supply 15 Brands and 50 Brand line extensions in over 240 stores in the country,” said Chomba Chuma, Managing Director, Vitabiotics SA. “Clicks is taking 26 line extensions exclusive to their stores for a period of time.”

In this partnership, Vitabiotics will increase their products by five new brands; Cardioace, Perferctil, Visionace, Wellteen, and Aquamarine and thirty-five brand extensions that did not exist in the South African market.

Dr. Chuma further added that some of these products were only available in Europe but this new partnership will enable their supply and increase the company’s market supply.

According to Health Products Association of South Africa, the nutritional supplements market in the country is worth over R3 billion a year and is estimated to be growing at about 24% annually.

Several incentives have pushed this growth such as; new product development, and an increasing number of patients in South Africa are seeking to self-medicate as a prevention measure, has gained momentum.

The continuous growing awareness of good nutrition has also motivated the industry. South Africa’s expanding middle class has also translated into higher disposable incomes and more stressful lifestyles, thus spending on vitamins, supplements, homeopathic remedies and spa treatments have grown considerably.

“Vitamins and dietary supplements have witnessed double-digit growth in the last few years,” said Chomba Chuma, Managing Director, Vitabiotics SA. “Multivitamins are also extremely popular due to the perceived practicality of having a combination of all the necessary vitamins in a single capsule. This partnership will now enable us to cater for this growing clientele.

Vitabiotics has been in South Africa for 4 years.

The firm identifies itself as one of the India’s largest manufacturers and exportere of biological products including:

• Protein Hydrolysates
• Peptones and derivatives
• Extracts
• Dehydrated Microbiological Culture Media
• Plant Tissue Culture Media
• Laboratory chemicals

Its products are utilised in the fields of agriculture, brewing and fermentation, clinical (medical), food, pharmaceutical, healthcare, sanitary testing, veterinary science and water.

For further information please contact:

Bichitra Barik
Business Development Executive (Export)

TITAN BIOTECH LTD
A 2/3 , 303- 305, 3rd Floor.
Lusa Tower , Azadpur Commercial Complex
Delhi,India – 110033

Direct ph. no: +91-11-47020100
Fax: +91-11-27674181
Ph: 09716003577
E-mail: export@titanbiotechltd.com

www.titanbiotechltd.com

www.plantissueculturemedia.com

Kollicoat IR Coating Systems:
Distinctive coloring, robust, protective and rapidly soluble: a new BASF tablet coating system enables individual, on-site production of tablet coatings in countless shades from only seven basic colors.

Since elderly people in particular may have difficulty telling tablets apart, more and more pharmaceutical manufacturers are starting to package active substances in colored tablets. A striking color supports and enhances treatment compliance and also prevents mix-ups during tablet production.

A combination of the tried and tested water-soluble BASF IR film former Kollicoat with a new production process and novel color concept makes tablet coating production more efficient. Its excellent processing properties are what make the polymer so special: Kollicoat IR has low viscosity and allows a shorter spray process because it can accommodate high concentrations of solids. As a result, pharmaceutical manufacturers cut their energy bills and spare the environment by reducing CO2 emissions in the production process. Other benefits: the granules are dust-free and have excellent flowability, which greatly simplifies handling during the production process. The BASF coating system module consists of just seven basic colors which are combined to produce the desired color. Hence, tablet manufacturers can optimize their inventories and the supply chain benefits from less complexity.

Kollicoat IR is a graft copolymer composed of polyethylene glycol and polyvinyl alcohol. It is extremely flexible and does not require additional plasticizer. The polymer dissolves rapidly in the stomach, resulting in prompt release of the active substance and rapid onset of action after the tablet is swallowed.

Stephen Saad, Aspen Group Chief Executive said “the excellent performance recorded by the South African business was driven by robust volume growth and margin improvements. Revenue growth in the international business is attributed to gains from Global brands, the Asia Pacific domestic brands, the oncology business and from the Glaxosmithkline (“GSK”) transactions.”

Completion of the GSK transactions:
With effect from 1 December 2009, Aspen completed a series of strategic, interdependent transactions with GSK (“the GSK transactions”) which had been announced on 12 May 2009.  The GSK transactions comprise:

•    The acquisition of the rights to distribute GSK’s pharmaceutical products in South Africa;
•    The formation of a collaboration agreement between Aspen and GSK in relation to the marketing and selling of prescription pharmaceuticals in sub-Saharan Africa;
•    The acquisition by Aspen Global of eight specialist branded products (Alkeran, Leukeran, Purinethol, Kemadrin, Lanvis, Myleran, Septrin and Trandate) for worldwide distribution;
•    The acquisition of GSK’s manufacturing facility in Bad Oldesloe, Germany; and
•    The issue by Aspen of 68.5 million ordinary shares to GSK at R66.80 per share amounting to a total value of R4.576 billion.

South African Business:
The South African business maintained its leadership position across the private and public sectors of the pharmaceutical market and grew revenue by 23% to R2.550 billion.  Operating profit from the South African business increased from R484 million to R806 million.  Other operating income includes an amount of R145 million received as insurance compensation for loss of profits and asset replacement arising from the explosion which occurred at the Nutritionals Facility in August 2009. Profit margins improved after the contractions in the previous two years caused by a weak Rand and delays in the passing of an increase to the SEP in the private pharmaceutical market.

The pharmaceutical division led growth in the South African business with revenue rising 30% to R1.975 billion.  Aspen’s robust growth in pharmaceuticals was characterised by volume gains across the extensive product offering.
.
The consumer division increased revenue by 6% to R575 million. This credible performance was recorded despite the prevailing recessionary effects in the retail environment as well as the negative impact on sales of infant milk formula due to the temporary unavailability of certain products resulting from the damage incurred at the Nutritionals Facility.

The Group’s South African manufacturing facilities achieved impressive efficiency gains as the benefits of the significant capital expenditure programme of the last few years begin to be realised.  The second Oral Solid Dose Facility and the eye-drop suite of the Sterile Facility commenced production at the Port Elizabeth-based site.  The hormonal suite of the Sterile Facility is scheduled to commence commercial production before the end of the 2010 financial year.  Capital projects in progress include the addition of increased tableting capacity and the installation of suppository and dutch medicines manufacturing at the East London site.  Reconstruction of the drying tower at the Nutritionals Facility is well advanced and production is expected to recommence within the next six months.

Sub-Saharan Africa Business:
In anticipation of the future materiality of this region, Aspen has established a separate management and reporting structure for the sub-Saharan Africa business.  Included in this business segment are exports into sub-Saharan Africa from South Africa, the Shelys Africa business based in East Africa and the GSK Aspen Healthcare for Africa collaboration.

Revenue from the sub-Saharan Africa business declined from R464 million in the prior period to R279 million and operating profit decreased from R99 million to R45 million.  The steep reversal in results was due to export business lost through the genericisation of patented ARV molecules marketed by Aspen. Sales by Shelys Africa were also reduced as this business shed low margin tenders in accordance with the strategic plan for the operation, without affecting profits.  GSK Aspen Healthcare for African began operations on 1 December 2009 and will in future be the most material contributor to the region.

International Business:
Revenue from the international business increased by 12% to R1.797 billion.  Gains from Global brands, the Asia Pacific domestic brands, the oncology business and the additional revenue from the GSK transactions were partially offset by reversals in Latin America.  Operating profit declined from R554 million to R463 million largely as a consequence of losses in Latin America and a strengthening of the Rand against most of the underlying trading currencies.

An 18% increase in revenue to R824 million from the Global brands is largely attributable to revenue from   Eltroxin, Lanoxin, Imuran and Zyloric, which were acquired with effect from 30 June 2008.  Worldwide sales from these four Global brands achieved double-digit growth in United States Dollars (“USD”).   The balance of the growth in the Global brands came from the addition of Aggrastat and the introduction of the eight products acquired from 1 December 2009 under the GSK transactions.

The Asia Pacific domestic brands increased revenue by 8% to R522 million.  This business, largely Australian based, again performed well considering the downward pricing pressure being experienced in this territory.

Aspen has exercised its call on the remaining 49% shareholding in the Latin American businesses.  Given that Aspen already has full rights to the economic performance of these businesses there is no further purchase consideration required for the acquisition of this remaining shareholding.

Revenue from domestic brands in Latin America declined by 15% to R345 million.  The primary underperformer was the Brazilian business, Aspen’s largest operation in the region. Aspen has assumed full operational control of the Brazilian business and has implemented a restructuring plan to shape this operation in accordance with the business model, which the Group has planned for Brazil.  Key actions include:

•    Disposal of selected assets, including the Campos Facility and related products to Strides Arcolab (“Strides”).  Consideration receivable from Strides amounts to approximately USD 75 million;
•    Right sizing of business structures and reshaping of sales teams to take account of the new business model; and
•    Identification and pursuit of opportunities to increase the private market product portfolio, of which some are at an advanced stage of negotiations.

The disposal of the Campos Facility will complete as soon as the requisite regulatory approvals are met.  In the interim, Strides have been engaged to manage Campos and will assume the risks and rewards of its operation.  An improvement in the performance of the Brazilian business is anticipated over the next six months as the restructuring plan takes effect.

The oncology joint ventures which Aspen has with Strides concluded a license and supply agreement with Pfizer in December 2009 in terms of which Pfizer has exclusive rights to market the oncology products in the United States.  An upfront non-refundable license fee of USD 12 million was brought to account in the six- month period to December 2009 of which 50% has been recognised, that being Aspen’s share under the joint ventures.

Funding:
Borrowings, net of cash, have been reduced from R4.0 billion at 30 June 2009 to R3.5 billion at 31 December 2009.  Strong operating cash flows and favourable exchange rate movements were the biggest contributors to this reduction.  The lower debt levels and the additional share capital in issue following the GSK transactions has resulted in gearing in the Group improving from 51% at 30 June 2009 to 29%.

Interest paid, net of interest received, of R190 million was covered seven times by earnings before interest, taxes and amortisation.  Gains on foreign exchange and forward cover contracts amounted to R32 million (2008 : R27 million loss) as underlying currencies strengthened against USD denominated obligations.

Prospects:
Aspen has established a leadership position in the South African pharmaceutical sector through more than a decade of unparalleled achievement in the industry.  The Group is positively positioned to maintain this leadership with an excellent product pipeline set to add to the most extensive product offering in the market and backed up by an outstanding team.  The recently awarded public sector tenders again verified Aspen’s production competitiveness, with the Group continuing as the largest supplier of pharmaceuticals to government.  The ARV tender remains to be awarded.  The ARV tender documents are yet to be published, although expectations are for an award to be made before the end of this financial year.  The recently announced support for local manufacturers under the South African Government’s Industrial Policy Action Plan is encouraging as is the focus on developing the pharmaceutical industry in South Africa.

The fundamental growth drivers of the South African pharmaceutical market remain intact.  This growth is however likely to be tempered by a delay in the annual SEP price increase by the Department of Health.  South African pharmaceutical companies will therefore absorb the net effects of exchange rate fluctuations and inflation from February 2010 until the date of the award.

Growth in the consumer business in South Africa is likely to be constrained by the economic circumstances.  Full supply of the infant milk products has been restored through the importation of product from Europe.  Overall performance indicators will continue to be distorted until full production is resumed at the Nutritionals Facility and the insurance payments are settled.

The sub-Saharan Africa business has excellent prospects.  The supplementation of GSK’s existing portfolio with Aspen’s pipeline of relevant products and supported by GSK’s proven distribution network should allow the GSK Aspen Healthcare for Africa collaboration to increase access to high quality medication in the region.  Shelys Africa has an active product launch plan for the remainder of the financial year as this operation becomes more focused on private sector business.

The transition of Global brands acquired in prior years to the Aspen international distribution network is well advanced.  Projects have been implemented which will result in significant cost of goods savings for the Global brands in the medium term and opportunities to supplement the Global brands portfolio will continue to be sought.

The biggest problem with the current therapeutic regimen for TB is that the drugs should be taken once a day for a period of six to nine months in order to be effective. Also, according to the World Health Organization (WHO) Direct Observed Treatment shortcourse DOTs programme, the drugs need to be taken in the presence of a healthcare practitioner, says Dr Boitumelo Semete, senior researcher in the drug delivery programme at the CSIR.

Due to logistics, cost and other considerations, this is problematic for South African patients, especially in rural areas. As these drugs furthermore have a number of nasty side effects, many patients never complete their treatment course. This slims down their chances of recovery quite significantly, says Semete.

She explains that to improve patient compliance with TB treatment, the CSIR team is developing a way that will ensure that the antibiotic drugs are released and taken up in the affected cells over a longer period of time, using nanoparticles. This means that patients will only have to take the drugs once a week instead of daily and the associated side-effects will be less. It is also hoped that, due to more effective delivery and improved bioavailability of the drug, the total treatment period will be significantly reduced.

The preclinical efficacy study just completed is strong confirmation of the potential of the drug delivery technology. While there is still a long road ahead before we can take our technology to human clinical trials and eventually make the treatment available to patients, we have just reached a significant milestone along the way, she says.