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Water Systems in Pharmaceutical Manufacturing: Facilities, Quality and Design Trends

Hany Onsy Fawzy

Mechanical Engineering, Faculty of Engineering and Technology, Helwan University

Water quality includes types of water in a Phanna plant, water quality

decision tree and requirements of each type of water manufacturing methodology in accordance to international nonns (USP and BP). While water purification steps and related governing parameters starting from city water and reaching to water for injection quality deals with pre- treatment, deionization / purification and distillation.

Different teclmologies are available to reach each purification step including pros and cons related issues as filtered water (Sandt Multimedia, dead end filtration), dechlorination (Carbon, chemical injection), softening (Resin treatment, chemical injection), purification (De-ionization, Reverse Osmosis, ED, UF) and distillation (Multiple effect, Thermo-compression).

Basics on validation of water systems include regulatory references and standards, information sources, general validation life cycle and list of qualification verification points at each qualification step. Actually auditing and inspection of pharmaceutical water system should be considered, either one is auditing or being audited.

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Recent Advances in Evaluation and Treatment of Back Pain

Youssry El Hawary

Orthopedic Surgery Department, Faculty of Medicine, Cairo University

Low back pain is one of the most common disorders of back. About 80 percent of people have at least one episode of low back pain during their lifetime. However, most people (>85 %) have "nonspecific low back pain", which is not caused by a specific disease or spinal abnormality. Many people attribute their back pain to degenerative disc disease, facet joint arthropathy , spondylolisthesis and herniated disc although problems in muscles or ligaments may be equally responsible. Rarely, back pain is caused by a potentially serious spinal condition, such as infection, fracture, tumor or a disorder called cauda equina syndrome. Back pain that is associated with leg pain can be due to a herniated disc or spinal stenosis. Common features of back pain are radiculopathy, sciatica and neurogenic claudication. Imaging tests used for evaluation include plain x-rays, CT scanning or an MRI may be recommended for people with certain conditions. Care of an attack of low back pain includes several simple elements as stronger pain medications, such as non steroidal anti. inflammatory drugs as well as muscle relaxants. Only a small minority of patients suffering from low back pain will require surgery. Surgery is necessary if there is evidence of cauda equina syndrome, persistent sciatica and serious back condition like a tumor, infection or severe weakness due to spinal stenosis or compression of a nerve root. It is important to differentiate between back pain and leg pain. Back pain is treated by lumbar fusion or recently by disc replacement. Disc replacement is now replacing the fusion techniques. Leg pain is treated by decompression.

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Chronic Pelvic Pain in Women Health

Awny Rahmy and Adly Sabbour Environmentel Expert, Cairo, Egypt

Pain is a signal that something is wrong. Regardless of its location, pain

should be investigated to confirm or eliminate its association with a specific cause or serious disorder. Chronic pelvic pain (CPP) is a common problem and presents a major challenge to health care providers because of its unclear etiology, complex natural history and poor response to therapy. CPP is a common problem. It affects approximately 1 in 7 women of all referrals to gynecologists.

Physical therapy is a profession known for musculoskeletal assessment and treatment for the purpose of decreasing pain, facilitating normal motion, and improving function in all daily activities. A variety of manual techniques may be used, including massage, soft tissue, mobilization, myofascial release, join mobilization, muscle energy, craniosacral mobilization and visceral mobilization. The use of these various manual methods is to affect not only is pain relief but also make a change in the body's tissues for the restoration of pain-free and optimal movement. The application of physical therapy agents – therapeutic heat, cold, ultrasound and electrical stimulation, have been basic to physical therapy practice for many years. With thoughtful application, these modalities can also be successfully used in the treatment of CPP.

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Health and Environmental Impacts of Chemicals

Mohamed El Zarka Faculty of Medicine, Cairo University

Properly employed chemicals contribute substantially toward a higher

quality of life. However, inappropriate handling of chemicals pose numerous risks and hazards for people and the environment, and such substances can become problematic at any point of their life cycle, i.e. during their production, handling, storage, use and disposal.

Developing countries and their populations are particularly endangered, as they tend to lack the requisite framework for the safe and proper management of chemicals.

The presentation will discuss the health and environmental impacts of chemicals and the proper behavior towards their management.

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Carcinogenic Toxins: Monitoring of Occupational and Environmental Cancer due to Toxic Agents with

its Health, Social and Economic Impacts

Mahmoud M. Amr National Toxicology Center ( NECTR), Faculty of Medicine,

Cairo University

Cancer is one of the most common and severe problems of clinical medicine. People differ in their susceptibility to particular cancers and in their sensitivity to certain carcinogens.

Implementation of primary prevention of cancer requires the identification of carcinogenic agents and of the conditions that favor the exposure of susceptible individuals to these agents.

A genetic basis- for the development of human cancer has been hypothesized for more than a century.

The transition from completely normal to frankly malignant occurs through a serious of steps or hits. Hits are mutations or other alteration of genes involved in regulation of cell growth and cell interactions.

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Psychobehavioural Changes among Workers Occupationally Exposed to Solvents

Mahmoud M. Amr, M. Shaheen Abd EL Azeem and

M.E. EL Taweel National Toxicology Center ( NECTR) and Department of Psychiatry ,

Faculty of Medicine, Cairo University

Some chemical and physical factors in the working environment not only affect physical health adversely but can be deterimental to mental health. In industry, solvents are the most common neurotoxic agents. The adverse psychological effects of working with solvents can be manifested in such functions as the memory and learning, in the sensory and motor functions and sometimes also in the intellectual functions. Personality characteristics may also be altered. Aims: This study was carried out with the aim of finding an association between solvent exposure in the work place and psychological, cognitive and behavioral changes among workers exposed to solvents. This is a cross-sectional study. Methods: 171 subjects working in a paint factory for at least five years were classified into group I (n = 109) (group with high or frequent exposure to solvents) and group II (n = 62) with low or less frequent exposure to solvents.

The control group (n = 40) were matched for the studied population as regards age, sex, marital and socio-demographic characteristics.

All groups were subjected to a full psychobiogram including : Kasr El-Aini Psychiatric Sheet with special emphasis and more detailed information concerning occupational history and chemicals used in work place, SCAN, MSHO, Hogstedt questionnaire to assess acute and chronic symptoms experienced by the subjects. Job stressors, coping and job satisfaction were assessed by McLeans questionnaire. Neurobehavioural performance among the three groups was assessed by WHO-NCTB. Also POMS was applied to

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assess emotional states. Biological monitoring for serum biochemistry and hematology was done. Results: The study came up with the following findings: There are significant difference in scores of both group (exposed I and II) and control for all disorders, acute and chronic .

The chronic symptoms: psychological, cognitive, neurological, and sleep symptoms showed higher significant differences between group I and the other two groups. McLean self assessment of work stress: Group I showed significant difference from each of the other two.

Middlesex Hospital Questionnaire (MSH): Anxiety, obsession, psychosomatic and depression subscales were significantly higher in group I

Neurobehavioural performance on WHO-NCTB subtests: showed significant impairment in group I.

POMS: Group I showed significant difference from each of the other two groups on tension-anxiety, anger-hostility, fatigue-inertia and depression-dejection subscales.

Correlation studies showed a significant relation between frequency of exposure to solvents (hours / day) and experiencing more acute symptoms. Duration of exposure to solvents (years) showed a significant correlation with poor performance on WHO-NCTB subtests, negative mood scales of POMs, abnormal or borderline results of hematology and serum biochemistry.

Conclusion and Recommendations include: Strategies for preventing neurotoxic illness as recognition and modification of risk factors, screening methods for early detection and periodic monitoring. Continuous improvement of the psychosocial environment and giving more attention to the psychological aspects to avoid humanization of working site.

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1 / 5

Economic Benefits of Environmental Pollutants

Salah M. El-Haggar Mechanical Engineering Department, The American University in Cairo

Air is the most important element for human life. We breath about 15

Kg of air per day as compared with the consumption of 2 liters of water and 0.5 Kg dry food. Air pollutants may represent a burden on the respiratory system and may contribute to morbidity and mortality. The respiratory diseases are covering a wide range of diseases affecting not only the lungs but also the mouth, throat, nose, eye, heart…etc. The respiratory disease-producing organisms are spread by coughing, sneezing, dust, contaminated indoor and out door air pollutants…etc. Smoking is another major contributor to respiratory diseases.

It should be noted that, air pollution might cause damage to property, equipment, crops and animals in addition to increased medical cost, labor hours and national economy. Global warming or climate change is considered recently the major disaster of air pollution and might destroy the world if no plans for mitigation and adaptation were developed.

Engineering controls of air pollutants through treatment should never be considered an equivalent solution compared with pollution prevention techniques. They should only be used after a thorough review of pollution prevention and cleaner production techniques to determine that process modification, technology changes recycling, product modification…etc are absolutely infeasible or can not be applied. This paper demonstrates the possibility of preventing or converting all types of air pollutants such as Carbon Oxides, Sulfur Oxides, Nitrogen Oxides, Hydrocarbon, ….etc into a product through Cleaner Production Techniques with value added .

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Health and Environmental Impact Assessment of Asbestos as a Carcinogenic Substance: Monitoring

its Fibrogenic and Carcinogenic Effects on Humans (Indoor and Outdoor) with their Economic and Social

Impacts

Mahmoud M. Amr National Toxicology Center ( NECTR), Faculty of Medicine,

Cairo University

Asbestos is divided into two main groups of minerals according to its crystalline structure; Serpentines and Amphiboles. Although it is hazardous and classified as a human carcinogenic,it has a wide use due to its rich combination of properties.

Asbestos is hazardous if it becomes airborne. Airborne asbestos can travel very large distances causing exposure to non-asbestos , working people.

Asbestos exposure causes many health problems.The accumulation of asbestos fibers in the lungs may cause several diseases. Mesothelioma is a Cancer of the chest and abdominal linings; it has a latency period of 15-60 years (Amr etal. 1999). "Fibrosis (Asbestosis) is another fatal disease that causes scarring of the lung tissues (Amr etal. 1989). some studies have shown that Chrysotile has much less impact on health than Amosite or Crocidolite. Asbestos combines Synergistically with cigarette smoke to multiply the risk of lung cancer.

Electron microscopy (EM) is the most reliable method to identify the asbestos fibers among the wide range of fibrous and non-fibrous particles.

Most common asbestos substitutes are aramid fibers, polyvinyl alcohol (PVA) fibers, cellulose fibers, glass fibers, ceramic fibers, polypropylene fibers, rock wool and wollastonite,galvanized, steel, PVC, ductile iron, aluminum sheets.

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Drug Misuse in the Arab World: Cultural Problem, Shortage of Knowledge or Both?

Alaaeldin Elkoussi

Professor of Pharmacology, Faculty of Medicine, Assiut University

To begin with, we should always make a clear distinction between "Culture" and "Knowledge" since we habitually fail to discriminate between these two different words and their meanings; especially in the Arabic language. Knowledge represents an important element in the culture of individuals and societies that embraces other vital factors such as: history, traditions, heritage, behaviors, principles, etc. When we discuss the drug use and misuse problem in the Arab World; an emphasis should be allocated to the significance of knowledge of the lay people as well as the members of the medical team in this regards. Physicians and pharmacists should learn more about drugs as they should realize their crucial role in improving the public knowledge and awareness about drugs, their beneficial and hazardous effects, indications, mechanisms, etc. We have to confess that during the last few years; the "true" physicians and pharmacists and for various reasons have abandoned their important role in this direction. This has given the opportunity to an immense number of non-specialists to replace them in the media and mislead the public to various myths, fallacies and deceits about drugs. In addition to some socio-economic and other factors; a remarkably amplified public trend towards the uncontrolled use of herbal and alternative medicine has prevailed. No one can doubt the potential benefits of the proper use of herbs in certain cases as nutrients, adjuvants or treatment for some minor conditions; and under appropriate medical supervision. However; this should never, under any circumstances, be generalized and adversely exploited for business or other motives. Confronting the drug misuse problem in any society would be accomplished only via raising the level of knowledge of the public about drugs and the scientific basis behind using them for treatment of diseases; and how the inappropriate use of other "substances" could harm the body. People should be given the chance to learn how to get adequate truthful information about drugs and their actions

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and from which sources. This is clearly the role of the media in collaboration with the medical professionals and organizations. Yet, we should not underestimate the essential educational role of the school and university regarding these important topics. No wonder that public health and drug education topics are always missing in our education systems in most of the Arab countries. This should be drastically and immediately changed and must be given its priority in developing the courses curricula in schools and universities. Students should be made aware of the differences between "true" and 'false" science and between "facts" and "myth" especially when it comes to health and health problems.

On the other hand; an access to adequate medical services should be looked upon as a genuine right for all citizens independent of their socio-economic status. Also, legalization and adequate legitimate control of the advertisement of herbs and other substances should be strictly undertaken.

Finally, it is needless to state that the problem of drug misuse in the Arab world needs more thorough assessment and analysis of its size, magnitude and causes in the different areas and among the different socioeconomic classes and societies. It is only through this scientific evaluation; that this important problem could be faced.

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Promotion of Rational Drug Use in the Arab Countries

Abdel-Aziz Saleh

Former Deputy Regional Director, World Health Organization, Eastern Mediterranean Regional Office

Drug expenditure in many Arab countries may reach more than 35% of

the total health expenditure. Several studies have shown that drugs in the Arab countries and world wide are:

� Irrationally prescribed by physicians; � Irrationally dispensed by pharmacists; and � Irrationally used by patients.

This behaviour has several serious clinical, economic and public health

consequences. Development of drug resistance, particularly antibiotic multi-drug resistance; exposure of patients to risks due to medication errors; and environmental pollution are among the main results of irrational use of drugs.

WHO in collaboration with ministries of health have developed strategies to promote rational use of drugs. These strategies are based on:

1. Policy framework where rational use of drugs is an important component of the national drug policy. It is important to carry out necessary surveys and studies to identify the magnitude of the problem and to test the best interventions that would be appropriate to the country or institution under study.

2. The development of national list of essential drugs based on the agreed upon standard treatment guidelines of major diseases.

3. Effective drug registration system of the drugs that have scientific evidence of their safety, efficacy, quality and cost effectiveness.

4. Establishment of drug and therapeutic committees at hospital and

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other health institutions to promote and implement institutional strategies to advocate rational use of drugs.

5. Encouraging medical and pharmacy schools to include relevant topics such as clinical pharmacology and clinical pharmacy in undergraduate education.

6. Informing the public and media of the importance of rational use of drugs.

7. Development and enforcement of regulations that ensure compliance with the professional and ethical practices related to drug use.