Akorn Pharmaceuticals Plant Hygiene - Research Paper Example

Industrial Hygiene Program al Affiliation According to the American Industrial Hygiene Association (AIHA industrial hygiene is an art and a science dedicated to the anticipation, recognition, evaluation, communication and control of environmental stressors in, of arising from, the work place that may result in injury, illness, impairment, or affect the wellbeing of workers and members of the community. These stressors can be categorized as chemical, biological, physical, ergonomic or psychological. Occupational hygienists have been involved historically with changing the perception of society about the nature and extent of hazards and preventing exposures in the workplace and communities. (Barry S. Levy, 2011, p3) An industrial hygiene program was set at identifying a major chemical plant established before 1970 and located in a relatively clean area. The plant identified was Akorn incorporation located in Illinois. The plant produced petroleum antiozonates and antioxidants, accelerators which contain rubber, and other pharmaceutical and cosmetic based products. The involved monitoring the production of different products in the company, establishing protocols for recommendation for a safe and productive environment. STATEMENT Provide support to the workers, conserve resources, enhance readiness, and preserve health by anticipating, recognizing, evaluating, and controlling health hazards to pharmaceutical and cosmetic working personnel at work and service. POLICY STATEMENT Akorn Quality Policy Statement it is Akorns policy to preserve and improve patient health by consistently delivering high quality, safe and effective specialty pharmaceutical products that meet or exceed customer expectations. (2014, November 26). Retrieved from http://www.akorn.com/about_quality.php Akorn Quality Mission Statement our management and employee workforce are committed to successfully deploying our companys Quality Policy to all aspects of our firm - assuring continued high quality, safe and effective Akorn products for our customers (2014, November 26). Retrieved from http://www.akorn.com/about_quality.php COMPANY PROFILE Akorn, Inc., whose founder is Taylor Pharmarcal, is a high-end pharmaceutical tasked with developing, manufacturing, and marketing both branded and unbranded prescription, consumer health, and animal health products. It was founded in 1940 at Illinois. Progressively, the firm has grown to be a paramount player in the pharmaceutical industry. Akorn has evolved to being capable of developing alternate sterile and non-sterile dosages which include: inhaled and nasal sprayed entities, otics, oral liquids as well as solids, injectables, opthalmics and topicals. Their products range from petroleum antiozonates and antioxidants, accelerators which contain rubber, and other pharmaceutical and cosmetic based products. Akorn, which has fully developed research facilities in Illinois, New York, Mauritius and India that guarantee long-lasting pipeline of newer products, recently acquired Hi-tech Pharmacal Co., Inc. and VersaPharm Inc. This major acquisition enabled it to further increase its manufacturing capabilities in all vital facilities (Retrieved from http://www.akorn.com/inv_corpover.php). HAZARD CHARACTERIZATION Working in a pharmaceutical industry can present specific hazards. The hazards can be from various potent compounds or from the equipment that are within the plant. The different drugs that are manufactured can give rise to different health disorders such as: 1. Vitamin Deficiency Workers with repeated exposure to antibiotics experience a change in the number and type of bacteria which are normally present in the intestines. These bacteria are the ones responsible for the breakdown and absorb vitamins in the intestines. 2. Allergic reactions Some drugs can give rise to allergic reactions such as reddening of the eyes, occasional shock due to allergy, constant itching, running nose, asthma, as well as rashes on the skin. Fungal Infections Daily exposure to antibiotic dust can read to fungal infections of the skin and nails. Additionally women workers may develop vaginal yeast infections following exposure to antibiotic dust. 3. Severe pounding headaches Nitroglycerin, commonly known as dynamite is a basis of several medicines for heart patients. Nitrates act on the blood vessels of the body and their effects are felt in several ways. Exposure to nitro dust leads to severe pounding headache which is cause by the relaxation of the blood vessels within the skull. Nitrates dilate the blood vessels and make blood pressure fall. As a result, dizziness and even fainting may occur. 4. Coma and deaths Tranquilizers can be habituating and addictive. In combination with alcohol, they may cause a person to lose consciousness and in high doses can lead to coma and death. Workers producing tranquillizers are at risk of these of these adverse effects and they may pass out over a bear after work. There is a real danger of accidents, both in the plant and on the way home, when workers become drowsy as a result of exposure to tranquillizers and barbiturates. (Adrian Hirst, 2010) The plant environment can read to several hazards. Machines that do most of the work in industries may produce noise, vibrations, heat, ergonomics, or electromagnetic beams. These hazards can be explained as follows. 1. Ergonomics Ergonomics is about the interactions of people with the machines they operate and their working environment. It aims to maximize human performance and to minimize discomfort, dissatisfaction and the risk of musculoskeletal injury. Simply put, ergonomics is all about fitting the task to the worker. If the match is poor, the best solution is to redesign the work tasks to make them more compatible with human characteristics. The scope of ergonomics is therefore very wide. Some common activities where ergonomics are important are: 1. Manual handling of loads; 2. Tasks involving repetitive actions; 3. The use of display screen equipment, such as when working with computers. The starting point for an evaluation of ergonomic factors is an assessment of the workplace. It should address: 1. Hardware, e.g. design and layout of machine controls, ease of maintenance, and machinery safety (guarding, interlocks etc.) 2. Software, e.g. standard operating procedures and instructions, manuals, and computer programs 3. Visual workspace, e.g. task/display design, display layout, information load, use of symbols. 4. Organization, e.g. working method, job content (degree of task variety and personal control), rate of work, satisfaction, communication, reporting, surveillance systems, management of conflict, etc. 5. Physical workspace, e.g. access, clearance, seating, work position, reach, storage arrangements, housekeeping etc. 6. Physical environment, e.g. temperature, noise, lighting, vibration substances hazardous to health, etc. 7. Individual characteristics, e.g. body size (anthropometry), strength, endurance, skill, training, motivation, attitude etc. (Adrian Hirst, 2010). 2. Noise It has become common practice to define noise, as unwanted sound and it has been known for many years as a cause of hearing loss in industry. So what exactly is sound and how do we hear it? Sound is the sensation that is perceived by the human or animal brain as a result of longitudinal vibrations of molecules of the air impinging on the ear. There are five possible health effects of noise: 1. Noise Induced Hearing Loss (NIHL) is a cumulative effect from repeated exposure. It is due to damage to the hair cells of the cochlea in the inner ear. First indication of hearing loss occurs with a reduction in the ability to hear around the 4 kHz frequency range. Over time, if the exposure continues the noise-induced hearing damage shows as an increase in the depth of the hearing loss and a widening of the 4 kHz notch to both lower and higher frequencies. 2. Tinnitus - Noise heard in the ear without an external cause; it frequently accompanies deafness. 3. Temporary Threshold Shift (TTS) – This is caused from the exposure to high noise levels which has resultant effects on the inner ear’s hair cells. It is imperative to note that there can be impairment of the ear temporarily due to these effects. To recover from this the noise level should be reduced over a period of time. 4. Physical damage to the eardrum and ossicles induced by excessively high noises e.g. explosions. This type of hearing loss is referred to as conductive hearing loss. 5. Annoyance/stress, which is difficult to measure and quantify, but may cause psychological effects such as poor concentration, irritability and stress (Adrian Hirst, 2010). 3. Vibration Vibration occurs when an object oscillates mechanically about an equilibrium point. The oscillations may be regular or random, examples being, the motion of a pendulum or the movement of a tire on a gravel road respectively. Health effects due to vibration entail measurement of the total "pressure waves" that are produced by vibrating equipment or structure. Vibration is channeled in the body from the part in contact with vibrating equipment. Hands and arms are affected when a worker operates heavy machinery such as jackhammer or chainsaw. The resultant is called hand-arm vibration exposure. Also, when a worker sits or stands perhaps on a vibrating seat or floor, the entire body is affected. This is defined as whole-body vibration exposure (Adrian Hirst, 2010). Vibration has adverse effects on almost every body part ranging from the muscles, tendons, bones and joints as well as the nervous system in rare cases. 4. Heat Some machines in processing plant produce a lot of heat. These heat might be harmful to humans around it. It is therefore of importance to note the most comfortable operating temperatures for the machine. Thermal comfort is very subjective and people will feel differently about what is the “ideal” thermal environment. Issues of thermal comfort manifest themselves at much less extreme conditions than those that may cause thermal stress. Indices have also been generated in an attempt to measure thermal comfort. E.g. the Corrected Effective Temperature (CET) and the Fanger Index. In manufacturing unit most machines have very high operating temperatures. This leads to workers being subject to similar environments. Possible adverse effects of exposure to excessive heat include; fatigue, behavioral modification, including reduced concentration, heat cramps due to salt loss, fainting heat exhaustion and heat stroke. Most pharmaceutical products are stored in controlled temperatures. These includes refrigeration where a few of the end products are stored in extremely cold environments. These exposes the workers working in these places to the same cold. Given one is exposed to excessive cold, he/she is bound to experience frost bite, hypothermia, chilblains and listlessness. 5. Electromagnetic radiations Light is a form of electromagnetic waves. Our working environments should be well illuminated to provide conducive working environments. General guidelines for designing illumination of sufficient quantity and suitable quality are: i) Consider lighting at the design stage of any building or workplace ii) Design for sufficient lighting levels in line with established guidance such as the CIBSE code iii) Integrate daylight and artificial light iv) Avoid glare v) Minimize flicker vi) Ensure adequate maintenance of glazing surfaces and light fittings. Electromagnetic radiations can further be categorized as Ionizing or non-ionizing radiations. Either of these radiations pose a great threat to human health on prolonged exposure. Radiation hazards can be categorized as either internal or external. An external radiation hazard is one from radiation sources outside the body of sufficient energy to penetrate the outer layers of the skin. The effects of external exposure can be summarized as: Minimal hazard, Skin and eyes at risk or Whole body at risk (penetrating radiation) An internal radiation hazard arises when the body is contaminated with a radioactive isotope. The presence of radioactive material in the body is often a more serious problem than exposure to external radiation because the radioactive material: a) Is in intimate contact with the body tissues and organs (remember inverse square law). b) Cannot be removed or shielded (irradiates the body 168 hr. /week). Entry to the body can occur through inhalation, ingestion, or skin absorption, in this situation, the effects of exposure are: Very serious hazard, Serious hazard or Not normally applicable. The nature of radiation is such that employees who work with radiation are normally subject to some form of health surveillance, including biological monitoring. Employees working in controlled areas would typically be subjected to: (Adrian Hirst, 2010) a. Completion of a questionnaire b. A blood test c. Urine test d. Blood Pressure check e. Height and Weight Check f. General discussion about health USES OF AGENT OR HAZARDOUS MATERIAL Akorn incorporated uses several agents in its manufacturing process. The manufacturing process is highly controlled to minimize contaminations and prevent agents exiting to the surrounding. These agents might be chemical, physical or biological. Some of hazardous materials in their cosmetic plant include; Synthetic colors, Phthalates Fragrance, Parabens, and Sodium laurel sulfate (John McCabe, 2007, p 267) EXPOSURES TO AGENT OR HAZARD Exposures to agent or hazard can be classified in several categories as. These are; Type of hazard (chemical, physical, and biological), Toxicity, Quantity in use, Duration of use, Past monitoring data, Established occupational exposure models. (Stanford University, 2007, p1) The hazards exposed to workers were dependent of agent interacted with. For the agents named above, the exposures exist. This was when some employees fail to follow safety protocols or when the environment does not offer the required safety. EMPLOYEE TRAINING OR EDUCATION Knowledge and training alone will not ensure safe manual handling but are an important aspect of a safe system of work. A suitable training program should address every aspect that affects IH. Employees are first trained before they start working in their respective plant positions. The training is comprehensive to give every worker exposures at every stage of production irrespective of their working position. Employees are also trained on how to handle emergency situations in case one of them is affected. Employees who suffer allergic complications are not allowed in most parts of the plant. MONITORING STRATEGIES AND BUDGET Some of the monitoring strategies were; Employee complaints of the presence of odor and Professional judgment and experience. Qualitative monitoring methods were also used which included; Personal air sampling, Area air sampling and swipe sampling. (Stanford University, 2007, p3) Other survey methods were; observation, individual request to discuss with plant supervisors and checking chemical purchases in the inventory. MONITORING SCHEDURE Biological Exposure Chemical Exposure Physical Exposure Radiations Exposure Administrative controls Engineering controls Eliminate Hazard MONITORING RESULTS Ergonomics results; Employees seemed to lack knowledge on how to do handle loads without endangering their bodies. Chemical results; most employees complained on the chemical exposures subjected to. After testing, existence of the risk was proved. These were subject to chemicals used at cosmetic plant as discussed earlier. Some employees failed to wear ear muffs, gloves, goggles and other safety cloths while in the plant Physical results; High temperatures regions were noticed in the plant. It was also noticed that some workers spend a lot of time there Biological results; Discussions with employees and their supervisors provided enough evidence that their health status has changed after they started working in the plant. This was evidenced by complains on allergic infections, skin infections, skin burns, reduced ear sensitivity and eye problems. REGULATIONS There is a regulation body for industrial hygiene in the United States. This organization is called OSHA (Occupation safety & Health Organization). The American industrial hygienists’ body is the (ABIH) American Board of Industrial Hygiene. These organizations offer rules to hygienists in industries. There rules control physical, chemical and biological factors. PROGRAM DESCRIPTION TIME TABLE FOR PHASES AND COMPLETION Action Date Member Member comments General Comments Challenges Completion Date Time spent Survey Questionnaire Monitoring Analyzing PROGRAM IMPLIMENTATION The program was implemented by each team member playing his or her role. All members were to discuss their findings after every exercise. A lot of corporation was displayed throughout the whole exercise. All challenges were tabled and discussed by all members. The goal of the program being to offer appropriate recommendations, all members were involved in creating recommendations after findings. PROGRAM AUDIT PHASE EQUIPMENTS START TIME COMPLETION TIME COST Survey Questionnaire Monitoring Analyzing PROGRAM EVALUATION The program was considered to be successful. The supervisors, employees and management of Akorn incorporation offered a lot of support to the program. They showed great interest to the program. Team members also offered their best. They showed their passion for the program. They also exercised their industrial hygiene skills accordingly. RECOMMENDATIONS From the results obtained, the following was recommended. Ergonomics results; Employees should be trained to recognize best operating positions according to each task under their docket. Chemical results; Employees should be encouraged to wear safety gear when in the plant. Those who fail to do so should be penalized. Some leakages were noticed in reacting chambers. These leakages should be stopped immediately when noticed. Physical recommendations: Amount of time spent for a single employee in either high or cold temperature regions should be minimized. Employees should be encouraged to operate in short shifts in these areas. Those allowed in these regions should also be medically fit to do so. Biological results; Discussions with employees and their supervisors provided enough evidence that their health status has changed after they started working in the plant. This was evidenced by complains on allergic infections, skin infections, skin burns, reduced ear sensitivity and eye problems. REFERENCES Hirst, A. (2010). Basic Principles in Occupational Hygiene (1st ed.). GlaxoSmithKline. Levy S. B., Wegman H. D., Sherry L. Baron, Sokas K. R. (2011). Occupational and Environmental Health: Recognizing and Preventing Disease and Injury. Oxford University Press, USA. McCabe, J. (2007). Sunfood Living: Resource Guide for Global Health. Stanford University, (2007). SLAC Environment, Safety, and Health Manual (SLAC-I-720-0A29Z-001), Chapter 5, “Industrial Hygiene” http://www.akorn.com/about_quality.php http://www.akorn.com/inv_corpover.php APPENDICES a. Attendance sheet DATE / TIME SURNAME FIRST NAME EXIT TIME SIGNATURE b. Work schedule Example NAME DUTY START TIME END TIME c. definitions OSHA – Organization of safety & Health AIHA - American Industrial Hygiene Association ACGIH - American Conference of Governmental Industrial Hygienists ASFE - American Society of Safety Engineers  ACS- American Chemical Society ATSDR - Agency for Toxic Substances and Disease Registry ANSI - American National Standards Institute Read More