Effect of seasonality on chemical composition and antibacterial and anticandida activities of Argentine propolis. Design of a topical formulation.

The effect of seasonality on Argentine propolis collected during one year on its phenolic and flavonoid content and on the growth of Gram-positive and Gram-negative antibiotic resistant bacteria and Candida species was evaluated. Extracts of propolis samples collected in the summer and spring showed higher phenolic and flavonoid contents than the samples collected in other seasons (5.86 to 6.06 mg GAE/mL and 3.77 to 4.23 mg QE/mL, respectively). The propolis collected in summer and autumn showed higher antibacterial activity (30 microg/mL) than the other samples (MIC values between 30 and 120 microg/mL). No antibacterial activity was detected against Gram-negative bacteria. Also, these extracts were able to inhibit the development of five Candida species, with MFC values of 15-120 microg/mL. Pharmaceutical formulations containing the more active propolis extract were prepared. The hydrogel of acrylic acid polymer containing summer propolis extract as an antimicrobial agent showed microbiological, physical and functional stability during storage for 180 days. The pharmaceutical preparation, as well as the propolis extracts, was active against Candida sp. and antibiotic-multi-resistant Gram-positive bacteria. These results reveal that propolis samples collected by scraping in four seasons, especially in summer in Calingasta, San Juan, Argentina, can be used to obtain tinctures and hydrogels with antibacterial and antimycotic potential for topical use.
sla MI¹, Dantur Y, Salas A, Danert C, Zampini C, Arias M, Ordóñez R, Maldonado L, Bedascarrasbure E, Nieva Moreno MI.

Design and quality control of a pharmaceutical formulation containing natural products with antibacterial, antifungal and antioxidant properties.

Ordoñez AA¹, Ordoñez RM, Zampini IC, Isla MI.
The aims of the present study were to determine the antibacterial and antifungal activity as well as mutagenicity of Sechium edule fluid extract and to obtain a pharmaceutical formulation with them. The extract exhibited antimicrobial activity against Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Acinetobacter baumannii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Candida spp. and Aspergillus spp. isolated from clinical samples from two hospitals of Tucuman, Argentina. Non-toxicity and mutagenicity on both Salmonella typhimurium TA98 and TA 100 strains until 100 microg/plate were observed. A hydrogel with carbopol acrylic acid polymer containing S. edule fluid extract as antibacterial, antimycotic and antioxidant agent was obtained. Microbiological, physical and functional stability of pharmaceutical formulation conserved at room temperature for 1 year were determined. Addition of antioxidant preservatives to store the pharmaceutical formulation was not necessary. The semisolid system showed antimicrobial activity against all gram positive and gram negative bacteria and fungi assayed. The minimal inhibitory concentration (MIC) values ranged from 20 to 800 microg/mL. Its activity was compared with a pharmaceutical formulation containing commercial antibiotic and antifungal. A pseudoplastic behavior and positive thixotropy were observed. Our current finding shows an antimicrobial activity of hydrogel containing S. edule extract on a large range of gram negative and gram positive multi-resistant bacteria and fungi. This topical formulation may be used as antimycotic and as antibacterial in cutaneous infections.

WHO Comments Signal Support For Compulsory Licensing In Pharma

Magazine Article | November 27, 2013

By Gail Dutton, contributing editor
The NIH recently made an unprecedented decision in granting the Lacks family some say in how the cervical cancer cells from the late Henrietta Lacks — the famed HeLa cell line — are used. A few months earlier, in May, controversy over ownership of a sample of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) erupted into a public spat involving the government of Saudi Arabia and Erasmus Medical Center in the Netherlands. In commenting, the WHO Director-General, Margaret Chan, demanded that labs not be allowed to profit from their work.
The underlying issue in both situations is the right to profit from scientific discovery. The ramifications of these incidents may affect not only the use of biological samples but also countries’ decisions to use compulsory licenses.
Developing World Unreceptive to Pharma Patents
The WHO appears suspicious of profitbased businesses. As Chan said in her WHO speech in May, “Many of the risk factors for noncommunicable diseases are amplified by the products and practices of large and economically powerful forces. Market power readily translates into political power. When public health policies cross purposes with vested economic interests, we will face opposition, well-orchestrated opposition, and very well-funded opposition.”
India, with a strong generic pharmaceutical industry, is particularly receptive to the notion of constrained patentability for pharmaceutical products. Earlier in 2013, India’s health ministry committee urged the government to exercise its compulsory licensing rights for Herceptin (trastuzumab). The Indian biopharmaceutical firm Biocon expects to complete Phase 3 trials of a biosimilar for trastuzumab this fiscal year, and Dr. Reddy’s Laboratories and Intas Pharmaceuticals indicate they may begin clinical trials soon. One year earlier, in March 2012, India exercised a compulsory license for Nexavar (sorafenib) by Bayer, which was subsequently produced by the Indian firm NatcoPharma.
When Roche relinquished its patent battles in India in August 2013, it cited India’s intellectual property environment as a key factor in that decision. Indian generics firms may see a boost from tight patent requirements and the exercise of compulsory licensing, but the results are chilling for innovators operating in India.
India’s success in exercising march-in rights has been noted by other nations. South Africa has an active campaign, spearheaded by the Treatment Action Campaign (TAC) and Médecins Sans Frontières (MSF), to remodel its patent laws after the Indian laws. In an August memorandum to the South Africa Department of Technology and Industry (DTI), TAC and MSF charged the lack of competitive markets in emerging regions enabled pharmaceutical companies to charge unaffordable prices that make life-saving medicines inaccessible.
“Although other BRICS [Brazil, Russia, India, China, and South Africa] countries like India and Brazil have utilized these pro-public health safeguards, South Africa is lagging behind and has not amended its patent law to incorporate or implement TRIPS [Trade Related Aspects of Intellectual Property Rights] flexibilities,” the TAC and MSF memo pointed out. It advocated a stringent patent examination process that “only grants patents on new drugs. If fewer secondary patents are granted, then more generic versions of medicines will be able to enter the market upon the expiry of compound patents, which will in turn drive down prices. Furthermore, when patents result in medicines being priced out of reach, actions that mitigate high prices, such as compulsory licensing, must be practically feasible to implement.” It called on DTI to “broaden the grounds and facilitate the procedures for issuing compulsory licenses.” Similar laws are enacted in China and are being planned in Argentina and the Philippines.
W. Murray Spruill, Ph.D., co-leader of Alston & Bird’s intellectual property patent proup and the leader of the law firm’s biotechnology, chemical, and pharmaceutical team, suggests these reactions are unrelated to Chan’s statements at the WHO meeting and that the willingness to exercise compulsory licensing rights in the United States is unlikely to change. “There was a lot of talk about compulsory licensing during the anthrax scare several years ago, but no compulsory license was granted in the U.S.,” Spruill says. “I don’t think it will be affected now.”
To exercise compulsory licensing in the U.S., the government must show that the company is not using the patent, the company is failing to meet a public demand, or the invention was funded partially by the government. The WHO agreement on TRIPS, in contrast, includes all patents.
The exercise of compulsory licensing in the EU is similar to that of the U.S. However, recent legislation allows a Europewide health emergency to be announced, with provisions to facilitate ordering vaccines for member states. Although the legislation does not address compulsory licensing, it does broaden the geographic scope of any actions. The EU Parliament says that, “Access to vaccines will be fairer, as they will be purchased at advantageous prices.”
Sample Ownership is Debated
Upstream from the patent issue lies the question of sample ownership. As Deborah Lacks, Henrietta Lacks’ daughter, says in The Immortal Life of Henrietta Lacks, “If our mother cells done so much for medicine, how come her family can’t afford to see no doctors? … People got rich off my mother … now we don’t get a dime. I used to get so mad about that …”
The issue with the MERS-CoV is only slightly different. Microbiologist Ali Mohamed Zaki, who uncovered the virus, says the Saudi Ministry of Health tested the sample for swine flu, then ceased testing. Zaki then sent a sample to virologist Ron Fouchier at the Erasmus Medical Center in the Netherlands for identification. The Saudi Ministry of Health says the sample left the country without permission, and disputes Zaki’s version of events. But, as Nobel Laureate Sir Richard Roberts, Ph.D., chief scientific officer of New England BioLabs, asserts, “It’s ridiculous to ban anybody from getting involved to help solve a disease.”
Saudi Arabia also claims viral identification was delayed three months because Erasmus Medical Center filed for a patent on the use of the virus’ DNA sequence and host receptor data. Other researchers point out that the virus sample is freely available and, in fact, has been analyzed by labs in many different countries. At that point, the WHO’s Chan entered the fray, forcefully telling meeting delegates that countries must not allow commercial labs to profit from MERS-CoV.
Yet, as Tilde Carlow, Ph.D., head of the division of parasitology at NEB, points out, “There must be some profit to drive R&D in our field. The consequence from not deriving profit could be really serious. There is an urgent need for new antibiotics, but because of the potential for meager profits, many companies aren’t interested.” Carlow predicts there will be a growing number of neglected diseases because of an inability to make a profit, thus hampering knowledge creation.
For-profit organizations aren’t necessarily getting involved in orphan diseases to make a profit, Roberts adds. “Some companies, like ours, have no desire to benefit financially, but instead want to solve a third-world disease.” For example, NEB became involved in lymphatic filariasis research some 30 years ago, before the WHO launched its own initiative in 2000. “Researchers at New England BioLabs are not interested in the commercial value of this research. We basically give away all the rights to anything we find here. We file patents, but do not charge licensing fees.”
Sample Sharing Guidelines Vary
The MERS-CoV flap illustrates confusion regarding the international rules for sharing samples, despite the pandemic influenza preparedness (PIP) framework the WHO developed to govern sample sharing. Under that framework, virus strains may be shared internationally with private companies as well as with public concerns. Countries sharing the virus receive equal access to the resulting treatments or diagnostics.
The guidelines for sample transfer and ownership vary, to some extent, by sample type. Within the Ocean Genome Legacy, which Roberts chairs, “There, the suppliers of the samples own the rights. With humans, however, it’s difficult to know who is the correct owner.” But, he points out, “Unless a researcher is there to isolate and characterize a sample, ownership doesn’t mean much.”
The question that remains is whether or how Saudi Arabia should benefit from the MERS-CoV. Nothing prevents it from developing diagnostic tests or therapeutics, either alone or in concert with other partners.
In the end, the spats regarding ownership of the MERS-CoV sample and the involvement of the Lacks family in determining who may use the HeLa cell line may be merely sideshows to a greater issue: the stance taken by the WHO and its perception of for-profit corporations. With the WHO’s tacit blessing, developing nations become more likely to tighten their patent laws and to exercise their compulsory licensing rights when they determine that medicines are unaffordable.

Prevention Instead of Decontamination

The highest possible quality of an end product, in compliance with requirements and regulations, can be attained only if quality assurance is not merely limited to final product testing. Rather, the entire manufacturing process, besides incoming quality control of the raw materials used, needs to be continuously monitored.

In the pharmaceutical industry, risk analysis of individual manufacturing steps is performed and the results of this analysis are used to define in-process quality control tests. Such QC tests permit timely detection of inconsistencies or non-conforming items and, in particular, increases in the bioburden as they occur in manufacture so that corrective action can be promptly initiated. Even though the risk of contamination has been considerably reduced by GMP-compliant production, decontamination, and sterilization of the end products, as well as by strict hygiene standards, quality control of the final product continues to be of prime importance.

Microbial enumeration

Quantitative analysis of microorganisms involves counting the colony-forming units (CFU), hence the term “microbial enumeration.” This number can be expressed either as the total viable number of CFUs in general or of certain product-relevant species of microorganisms. This is why microbial limit tests are performed on various products from different sectors, including the pharmaceutical, beverage, and waste water industries, to ensure that defined limits are not exceeded. The accuracy and reliability of microbial limit test results are essential as they serve as the basis for the release of products, whether potable water or pharmaceuticals, and the impact of undetected pathogens can be potentially devastating on the health of consumers.

Membrane filtration

For microbial enumeration, membrane filtration continues to be the method of choice for reliable quantification of microorganisms in liquid samples. The principle of this method is based on the concentration of organisms—which are filtered out from relatively large sample volumes—on the surface of a membrane filter and their subsequent cultivation by incubating the filter with the retained microbes on a culture medium.

Unlike direct incubation of a sample, membrane filtration offers the advantage that large sample volumes can be tested without individual microorganisms going undetected. In addition, inhibitors, such as antibiotics or preservatives, can be removed by rinsing the membrane with buffer so that microbial growth is not suppressed.

Microbiological tests in the pharmaceutical industry

From a microbiological viewpoint, pharmaceuticals can be subdivided into two categories: non-sterile and sterile products. For both categories, the potential risk resulting from microorganisms and their toxins on patients’ health must be eliminated or at least mitigated. At the same time, the quality and effectiveness of such pharmaceuticals must be retained.

Products defined as sterile, such as eye drops, physiological saline, antibiotics, etc., need to be tested for sterility (USP Chapter 71 and EP, Chapter 2.6.1) in order to be verified as such. Unlike sterile products, non-sterile end products are tested for their number of viable microbes according to the microbial limit test (USP Chapter 61 and EP Chapter 2.6.12). Furthermore, in the pharmaceutical industry, in-process microbiological quality control tests are carried out on raw materials, mostly water, as well as bioburden analysis during manufacture.

Critical steps in microbial enumeration

The classic equipment setup for performing membrane filtration consists of a vacuum pump, a multi-branch vacuum manifold, membrane filters, reusable funnel-type filter holders or single-use filtration units, culture media, and tweezers.

In this method, the filter support of a reusable filter holder is sterilized by flaming, and a membrane filter is subsequently placed on this support. Then the funnel is attached to the support and a sample is poured into this funnel. Filtration begins when the tap on the vacuum source is opened. At the end of filtration, tweezers are used to remove the membrane filter and transfer it to an agar culture medium.

The culture medium is incubated for a defined time at a predetermined temperature inside an incubator. At the end of incubation, evaluation is done by enumerating the individual CFUs and comparing their count with the permissible microbial limits for each particular sample.

Flaming or disinfecting the filter support poses an added risk of contamination due to the inherent inaccuracy in performing these sterilization procedures. In particular, maintaining the required time of contact with the flame or disinfectant, the choice of disinfectant (not just a bactericide, but a sporicide) and regular changing of the disinfectant are all critical factors in determining whether sterilization is 100% effective. Besides representing a health hazard for lab personnel, flaming also poses the risk that not all areas contaminated by microbes are exposed to the hottest point of the flame long enough in order to kill off these organisms.

Minimization of secondary contamination

A single-use filter unit does not require any decontamination, provided that a single-use filter base is used. As a result, the only especially critical step that remains is transferring the membrane filter to an agar medium, which increases the risk of secondary contamination and can lead to false-positive results. The reason lies in the use of tweezers to transfer the membrane. Although these tweezers are also flamed, i.e., sterilized, they can potentially carry over exogenous microbes when used to grasp the membrane.

Single-use filter units increase the safety and efficiency of microbiological quality control by eliminating the need for disinfection or flaming of the filter support, as well as for using tweezers to transfer a membrane to a culture medium. A system comprised of single-use filter units and agar media dishes can increase efficiency and reliable results.  

The filter unit in this type of system is a sterile, ready-to-use combination of a funnel, a filter base, and a gridded membrane filter. This filter unit is connected to a stainless steel multi-branch manifold in order to directly filter a sample. Afterwards, the filter unit is easy to remove from the manifold and eliminates the critical step of decontaminating the stainless steel base of a reusable filter holder.

Agar media dishes are used for microbial limit testing. They are pre-filled with different types of agar medium, sterile-packaged and, when together with a single-use filter, are ready to use immediately. In combination with a single-use filter unit, these media dishes feature an active lid that permits touch-free transfer of a membrane onto agar, without using any tweezers. This active lid lifts the membrane filter from the base of the filter unit so the filter can be safely transferred onto the pre-filled agar dish. Once the medium dish is closed, the membrane is ready to incubate.

Solution for safe membrane transfer

The combination of agar media dishes and filter units represents a new membrane transfer and agar concept. As just a few steps are all it takes to proceed from sampling to incubation, a single-use system of agar media dishes and filter units accelerates workflows, making them cost-efficient. At the same time, touch-free membrane transfer enables even more reliable results to be obtained in analysis, while reducing secondary contamination to an absolute minimum.

Three Consecutive Batches for Validation in Pharmaceuticals

This is common concept to validate three consecutive batches in pharmaceuticals. In process validation initial three batches are taken for validation. This is a basic question that concentrates everyone’s mind that why three batches are taken for validation?

Neither FDA nor any other regulation specifies the maximum number of batches to be considered as validation. The manufacturers have to choose the number of batches to be validate in this regard. The number of batches to be taken under validation depends upon the risk involved in the process of manufacturing. The less knowledge about the process requires the more statistical data to confirm the consistent performance. Consideration of validation batches fewer than three will require more statistical and scientific data to prove the consistency of process to meet quality standards.

FDA’s “Guidance for Industry on Process Validation: General Principles and Practices” provides the guideline for process validation, no longer consider the traditional three batch validation appropriate but also does not prescribe the number of batches to validate or suggests any other method to determine it.

Related: Guidance for Industry on Process Validation: General Principles and Practice

Generally it is considered if we get the desired quality in first batch, it is accidental, second batch quality is regulator and quality in third batch is Validation. When two batches are taken as validation the data will not be sufficient for evaluation and to prove reproducibility because statistical evaluation cannot be done on two points, it needs minimum three points because two points always draw a straight line. Therefore, minimum three consecutive batches are evaluated for validation of manufacturing process and cleaning procedures. More than three batches may be taken in validation but it involves the cost and time and the companies don’t want to do so.

Contamination Control

It’s only natural that contamination control in today’s world of critical environments is in a constant state of evolution. After all, the complexities of facilities and processes flow from the increasing intricacies of end products. And throughout the continued development of environmental monitoring programs, it pays dividends to recognize that what works today may not be the best solution for the future.

Wet wiping is a cornerstone of contamination control. A liquid’s ability to penetrate and sanitize the nooks and crannies of a surface—coupled with a process-appropriate sorptive material for absorption—will remain crucial to critical environments across industries.

Alcohol is a lasting standard for wet wiping. While it doesn’t have the broadest kill spectrum or the highest surface penetration, it is a gentle yet effective sanitizer and reliable dissolver of ionic compounds and common organics. Alcohol also evaporates cleanly enough to be used as a residue remover for many other cleaning chemicals. Pairing alcohol—often in a 70% IPA/30% USP purified DI water mixture—with a knitted polyester or polyester-cellulose wipe has been a reliable choice for wide-ranging critical cleaning applications.

It’s necessary to consider that the process you designed two years ago may not be effective two years from now. If this transpires, will your current supplier be able to meet unanticipated process needs? While it’s important to recognize the potential costs of product evaluation and risks associated with changing suppliers, assessing your supplier’s innovative and evolving capabilities is an equally important consideration.

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Pharmaceutical Industry Undergoing Transformation

• Although the pharmaceutical industry’s investment in R&D has doubled in the past decade, fewer than half as many new products actually make it to market. Consequently, the business model of creating a handful of blockbuster drugs and marketing them to providers is no longer sustainable. As the industry responds to this new imperative, it will see more changes by 2020 than it has in a generation.
  Change is necessary because more of the same won’t work. Blockbuster drugs are coming off patent, fewer new products are in the pipeline because of a lack of fundamental innovation, sales and marketing expenses are increasing, regulatory costs are growing, and there has been a dramatic loss of trust in the industry. As a result, returns on pharmaceutical stocks have lagged behind those of other industries—during the past six years, the Dow Jones World Index rose 34.9% while the FTSE Global Pharmaceuticals Index rose just 1.3%. The pharmaceutical industry is relatively weak financially and cannot respond simply by throwing more money at the challenges it faces.
  However, the industry’s future is brighter than it seems because estimates indicate that the worldwide pharmaceutical market will more than double by 2020 to $1.3 trillion in annual sales. Demand will come partly from an older, larger, and more sedentary population, especially from new markets in developing countries.
  In addition, the incidence of some existing diseases are increasing, partly because of climate change, which is expanding the geographic range of tropical and semitropical infectious diseases. Chronic respiratory illnesses are increasing as well, as new factories and auto travel worsen air pollution in developing countries. Also, new diseases, many of them resistant to existing therapies, are emerging.
  As the pharmaceutical industry seeks to address challenges and make the most of strategic opportunities, it will see 10 transformational challenges by 2020:
  

• Transformations

  1. The industry’s reliance on the blockbuster model will decrease. Rather than relying primarily on a handful of blockbuster drugs, the industry will shift to developing a wider range of medicines. Sales and marketing also will change, as today’s enormous sales forces are replaced by smaller teams that will negotiate prices based on proven benefits and sell related services that may add more value than the medicines themselves.
  2. The pharmaceutical industry will become increasingly bifurcated, with some companies becoming niche players, developing fewer, more targeted drugs; others will go the generic route, focusing on volume and sales for revenue. Companies can succeed on either path but will have to choose which way to go.
  3. Real results will be crucial to product success. Products will have to produce value, and companies will profit from innovation, not by replicating existing therapies. As a result, greater focus will be placed on obtaining results supported by measurable data.
  4. There will be a new focus on patient compliance. Patients often do not take their medications as prescribed or fail to take them entirely. Pharmaceutical companies will develop new, personalized compliance-monitoring technologies and techniques to ensure that patients take their medicine, improving results and safety while potentially generating more than $30 billion annually in new sales.
  5. Prevention will become as important as treatment. “A penny of prevention is worth a pound of cure” takes on added meaning when billions of dollars are at stake. The pharmaceutical industry has long been focused on treatment of disease but it will be far more cost-effective to prevent disease than to cure it, and this will be a driver of innovation. With consumers increasingly focused on healthcare costs, pharmaceutical companies will also begin supporting wellness programs, compliance monitoring, and increased vaccination.
  6. Technology will transform R&D. New molecular technologies will help realize the promise of genomic research, and the growing sophistication of medical devices, often in combination with drugs, will improve therapeutic effectiveness while cutting risk.
  7. The clinical trials process will become more flexible. Today’s all-or-nothing regulatory approval process will shift to a more progressive system of in-life testing and “live licenses,” which will be based on a drug’s performance over time, with greater collaboration and data-sharing between pharmaceutical companies and regulators. This will also depend on the arrival of pervasive computing to the home and the ability to monitor patients remotely.
  8. The regulatory process will go global. As international markets become more important, pharmaceutical companies will spur a drive for greater cooperation among national regulators to get lifesaving products to market faster and reduce regulatory compliance costs.
  9. Supply chains will become revenue generators. Applying just-in-time manufacturing and delivery systems used in other industries, pharmaceutical companies will develop products on a made-to-order basis, creating new channels to market products.
  10. Wholesalers will give way to direct-to-consumer distribution. As the over-the-counter product market grows and new technologies enable direct-to-consumer distribution, reliance on wholesalers will diminish with more prescriptions fulfilled automatically.
  

• Success in the Future

  Like other sectors of healthcare, the pharmaceutical industry will see enormous changes that will render many of today’s practices, standards, and operations unrecognizable by 2020. The long-term success of today’s industry leaders is by no means guaranteed but instead will be determined by their ability to adapt to new realities. The winners will be those companies that have the vision, flexibility, and courage to begin making changes now.
  Pharmaceutical companies can prosper through adaptation—investing in research to produce products that yield results at realistic prices, collaborating with stakeholders here and abroad, and providing consumers with services that add value. The stakes and the risks are high but so are the potential rewards.
  

A Mini-Guidebook On Cleanrooms

By Themedica on August 25, 2008 5:09 AM | Permalink

                   

A cleanroom is an enclosure used in manufacturing or in hospitals wherein a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors needs to be maintained. These low levels of environmental pollutants are monitored and maintained with the aid of special equipment meant for the purpose.

Further, the controlled level of contamination is specified by the number of particles per cubic meter at a specified particle size.

Cleanrooms can be of variable sizes based on the requirement. For instance very large cleanrooms are often used in manufacturing facilities, or even the whole of a manufacturing unit may be built into a cleanroom. For the most part, they have applications in semiconductor manufacturing, biotechnology, life sciences and other fields that are acutely sensitive to environmental pollution.

The working of a cleanroom entails an air filtration unit so that the air entering a cleanroom is filtered to exclude contaminants, while the air inside is recirculated by means of high efficiency particulate air (HEPA) and ultra low penetration air (ULPA) filters. These filters are meant to clean up the pollutants generated due to the processes taking place inside the cleanroom.

There are also airlocks, typically with air shower stages, at the entry and exit points of cleanrooms. Usage of protective clothing such as boots, gloves, face masks and cover-alls is the norm for staffers.

Furthermore, the equipment inside the enclosure is specially designed to produce the minimum levels of pollutants. Office stationary viz. paper, pencils for use are made from natural substances or at best aren't allowed inside. Additionally, many cleanrooms are kept at a positive air pressure, so as to prevent any contaminated outside air to get in, in case there's a leakage.

Some Common Types of Cleanroom Supplies

As already outlined, there are a host of equipment and supplies that are specially designed for use in clean rooms. Some classes of essential supplies for cleanrooms are described below.

Cleanroom Disposables

Cleanroom disposables refers to all the products, items and packaging used once or only a few times within the cleanroom before being discarded. Examples of cleanroom disposable include Medical and Cleanroom Apparel, that is clothing and masks used in healthcare and pharmaceutical cleanrooms, or gloves meant for handling cytoxic formulations, etc. or Specialty bags and Packaging such as Light Inhibiting Bags, Sterile & Isolator Waste Bags or Theater Products meant to control contamination operation theater environment which entail supplies like floor mats, camera bags, filters, etc.

Cleanroom Equipment

Cleanroom equipment refers to tools, devices or other items necessary used in carrying out critical processes within cleanrooms, while maintaining a pollution free environment. They could include Cleanroom Furniture viz. Operator/Technician Workbenches, Seating, Laboratory Furniture, Mobile Trolleys etc. or Cleanroom Wall Systems such as Demountable Partitions, Cleanroom Doorsets, Pass Through Hatches, Wall Cladding Systems and the like, or items needed for Cleanroom Laminar Flow like Laminar Flow Hoods, HEPA Filtered Fan Modules, Fume Cupboards, Air Showers, etc. Pass Thru Air Locks, Wet Process Stations, Cleanroom Garment Racks, Step Ladders are some other necessary cleanroom equipment.

Cleanroom Garments

Cleanroom Garments refer to clothing that prevents the contaminants on the body to mingle with the clean environment within a cleanroom enclosure. Cleanroom garments are made of selected fabrics viz polyester, that are durable, lightweight and have other desirable properties. They are designed to meet the most stringent requirements of cleanliness that cleanrooms warrant. Examples of such garments include special Gloves, Masks, Shoecovers, Coveralls, Gowns and Smocks, Head Covers, Undergarments, etc.

Cleanroom Services

Once a cleanroom has become operational it requires a series of maintenance procedures carried out at set time intervals or as needed, to ensure the upkeep of its 'cleanroom' status. Controlling and maintaining contamination is the hallmark of cleanrooms and expertly trained technicians and sophisticated gadgets are often needed to conduct effective cleanroom services. Some examples of cleanroom services include regular Floor Care and Testing /Certification, Cleanroom Cleaning, Clean Room Sterilization, Micro-cleaning, Contamination Control, Protocol Development, Particle Count Certification, Sterile and non-sterile garment services, Cleanroom Training & Consulting, Cleanroom Audit, etc.

Tips For Ordering Cleanroom Products and Services

For the most part it's the quality of cleanroom products based on the requirements that determines their effectiveness. Supply and distribution of substandard cleanroom products poses a major challenge for buyers and consumers of these products. Use of substandard products can result in major losses to the users of these products. Quality of cleanroom supplies can be ensured to quite an extent through the following meassures.

1.Establish the integrity of the source prior to need.
2.Establish a list of approved suppliers.
3.If you source from an alternative source ensure that at least the following information is provided:
    a. A pedigree back to the previous source
    b. Certification that it is not a diverted product
    c. Certification that any actions by the alternative source will not alter any original manufacture warranties or         guarantees
    d. Certification that the product has been stored and handled consistent with product labelling requirements

4.Be wary of cleanroom products that are offered at an unusually cheap price.

5.Make a list of key cleanroom equipment that will not be purchased from any other source but the manufacturer, or authorised distributor.

6.Look for changes in the product’s package and compare them with previously purchased products, tears in the sealing tape and seals and variations in the size of the container.

Industry Overview

North America and Europe are the major markets for cleanroom products and services. The demand for cleanroom consumables in the US has grown at an annual rate of about 6 percent through 2007. Aside from the medical industry, the semiconductors industry and expansion of clean room technologies are the drivers of this growth. Products with the maximum demand will be drugs, hard disk drives, foods and beverages, flat panel displays, chemicals, apparel, wipes and swabs. The US market for clean room consumables is estimated to be worth US$ 1.2 billion.

Europe makes up for about 28% of the world's market. France and Germany are the leading European buyers of pharmaceutical clean rooms. The demand for clean room technology to be used in the pharmaceutical and biotechnology industry is on the rise. Moreover, the bio/pharmaceutical industry is the Europe's second largest consumer of clean room space.

Much of the demand for cleanroom products and services attributed to pharmaceutical industry is centered around contamination, where presence of bacteria and viruses can have a devastating effect on medicines packaged as tablets, capsules, liquids, etc.

As for investments, the year 2000 saw the European pharmaceutical and biotechnology firms spend $128 million on new clean rooms. Whereas the expenditure was US $542 million for the entire European industry on new clean rooms, during the same year. From 2002 through 2006 the clean room consumables purchases by the European industry rose from US $121 million to US $151 million.

The world market for clean rooms on the other hand grew from US $6.5 Billion in 2000 to US $9.1 Billion by 2006.