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Pharmaceutical industry - 176 entries found

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CIS 11-0698 Murray W., White J., Ison S.
Work-related road safety: A case study of Roche Australia
This paper describes a successful, on-going real-world case study of an Australian company car fleet that has effectively managed, monitored and improved its road safety performance over the last four years through a range of proactive, fleet manager, insurance and risk-led initiatives. The case describes the four key initiatives that have been successfully implemented by the company, with support from their fleet insurance and risk management partners: driver risk assessment, monitoring and improvement programme for all existing and new employees; policy development, review and enhancement; communications programme; on-going review and refinement of policies, processes and programmes.
Safety Science, 2011, 9p. Illus. 30 ref.
Work-related_road_safety.pdf [in English]


CIS 11-0767 GlaxoSmithKline: Towards still better training
GlaxoSmithKline: vers une formation toujours plus performante [in French]
This article presents the policy, the organization, the programmes and the activities of a Belgian pharmaceutical company in the area of occupational safety and health training.
Prevent Focus, Sep. 2010, p.16-19. Illus.

CIS 11-0545 Martínez de Linarez M., Berrade Urbano C., Obiols Quinto J., Solans Lampurlanés X.
Manufacture of pharmaceutical active ingredients and potent drugs. Facilities and personnel
Fabricación de principios activos farmacéuticos y medicamentos potentes. Instalaciones y personal [in Spanish]
This technical note establishes design criteria for facilities involved in pharmaceutical active ingredient manufacture, aimed at minimizing the potential risk of workers' exposure to these substances, as well as the requirements to be met by personnel handling these substances.
Instituto Nacional de Seguridad e Higiene en el Trabajo, Ediciones y Publicaciones, c/Torrelaguna 73, 28027 Madrid, Spain, 2010. 6p. Illus. 12 ref.
NTP_879.pdf [in Spanish]

CIS 11-0398 Obiols Quinto J., Solans Lampurlanés X., García Martínez V.
Prevention of exposure to active ingredients in pharmaceutical industry laboratories
Industria farmacéutica: prevención de la exposición a principios activos en los laboratorios [in Spanish]
This information note explains the measures for preventing exposure to active ingredients in pharmaceutical industry laboratories depending on the forms in which these substances are handled (powder, liquid) and their level of toxicity.
Instituto Nacional de Seguridad e Higiene en el Trabajo, Ediciones y Publicaciones, c/Torrelaguna 73, 28027 Madrid, Spain, 2010. 8p. 8 ref.
NTP_855.pdf [in Spanish]


CIS 12-0269 Moore P., Wintle J.
Health and Safety Executive
Establishing the requirements for internal examination of high hazard process plant
The objective of this study was to develop guidelines for internal examination for high hazard process plants. A series of visits was made to United Kingdom companies to establish their approach to drawing up written schemes of examination. Discussions were held with three oil refineries, two sites manufacturing ethylene, a leading engineering consultancy, a large pharmaceutical company, and an engineering insurer that acts as a third party inspectorate for a wide range of companies not limited to petrochemicals and pressure plant. Findings are discussed and recommendations are proposed.
HSE Books, P.O. Box 1999, Sudbury, Suffolk CO10 2WA, United Kingdom, 2009. vi, 35p. Illus. 21 ref.
Establishing_the_requirements_[INTERNET_FREE_ACCESS] [in English]

CIS 09-1379 Rosenberg N.
Occupational respiratory allergy to small laboratory animals
Allergie respiratoire professionnelle aux petits mammifères de laboratoire [in French]
Occupational respiratory sensitization to small laboratory mammals applies to biological, medical and pharmaceutical research. The condition is generally immuno-allergic and IgE-dependant. The most common allergens have been identified and characterized, in particular for rats and mice, the most frequently-involved species. Diagnosis usually relies on symptoms linked to contact with animals and positive skin or serological tests. Various preventive and protective measures are discussed.
Documents pour le médecin du travail, 4nd Quarter 2009, No.120, p.471-479. Illus. 43 ref.$File/TR47.pdf [in French]

CIS 09-1313 Neumark M., Moshe S., Ingber A., Slodownik D.
Occupational airborne contact dermatitis to simvastatin, carvedilol and zolpidem
A 26-year-old atopic male machine operator in a pharmaceutical factory with a six-month history of dermatitis on his eyelids, cheeks, lips, nose and nasolabial folds was referred to the dermatology department of an Israeli hospital. Patch tests were carried out with standard series and specific products, including chemicals used in the plant. Positive reactions were found to three of these substances (simvastatin, carvedilol and zolpidem).
Contact Dermatitis, July 2009, Vol.61, No.1, p.51-52. 3 ref.

CIS 09-1048 Youk A.O., Buchanich J.M., Marsh G.M., Cunningham M., Esmen N.A.
Pharmaceutical production workers and the risks of mortality from respiratory system cancer and lymphatic and hematopoietic tissue cancers
The objective of this study was to evaluate further elevated mortality risks from respiratory system cancer (RSC) and lymphatic and haematopoietic tissue cancers (LHTC) in a cohort of 1466 male workers employed full-time in a pharmaceutical production plant. Standardized mortality ratios were computed and mortality risks evaluated in nested case-control studies of RSC and LHTC. While subjects had no elevated RSC risk, a statistically significant LHTC excess was observed. LHTC risks increased with increasing levels of average exposure to dimethylformamide. Implications of these findings are discussed.
Journal of Occupational and Environmental Medicine, Aug. 2009, Vol.51, No.8, p.903-915. 35 ref.


CIS 08-164 Laukkanen A., Ruoppi P., Remes S., Koistinen T., Mäkinen-Kiljunen S.
Lactase-induced occupational protein contact dermatitis and allergic rhinoconjunctivitis
This article reports a case of protein contact dermatitis and allergic rhinoconjunctivitis from occupational exposure to lactase in a female pharmaceutical worker in Finland. The patient exhibited strong positive responses to lactase in prick tests. In an open application test, lactase elicited whealing, and in patch testing, lactase elicited an eczematous reaction. Serum lactase-specific immunoglobulin E (IgE) antibodies were demonstrated in immunospot and radioallergosorbent test assays, and lactase-IgE-binding fractions were examined in immunoblot and immunoblot inhibition assays. The chamber challenge test was performed to detect the association between lactase sensitization and rhinoconjunctival symptoms. The results confirm previous observations that lactase can induce occupational IgE- mediated respiratory and conjunctival sensitizations, but in addition show that contact skin reactions caused by lactase may also occur.
Contact Dermatitis, Aug. 2007, Vol.57, No.2, p.89-93. Illus. 19 ref.

CIS 08-151 Milković-Kraus S., Macan J., Kanceljak-Macan B.
Occupational allergic contact dermatitis from azithromycin in pharmaceutical workers: A case series
A series of seven cases of occupational allergic contact dermatitis (ACD) caused by azithromycin in Croatian pharmaceutical workers is described. Seven out of 21 workers exposed to powdered intermediate and final substances in azithromycin synthesis were referred with workplace-related skin and respiratory symptoms. They all underwent a diagnostic procedure involving medical history and medical examinations, patch testing with standard allergens and azithromycin, prick testing with inhalatory allergens and total . ACD caused by azithromycin was established in four examined workers showing a positive patch test to azithromycin. Two workers additionally showed a positive patch test to intermediate substances. Other findings are discussed.
Contact Dermatitis, Feb. 2007, Vol.56, No.2, p.99-102. 16 ref.


CIS 07-364 Ostiguy C., Lapointe G., Tottier M., Ménard L., Cloutier Y., Boutin M., Antoun M., Normand C.
Health effects of nanoparticles
Quebec is very active in research in the field of nanoparticle development and nanotechnology. More than 35 production companies already exist or are in the start-up phase. It is believed that the number of Quebec workers potentially exposed will grow over the next few years. To prevent the development of occupational diseases or the occurrence of accidents, the IRSST began a review of scientific knowledge to evaluate whether there are known risks associated with this emerging sector. This report summarizes current knowledge on the toxicokinetics and effects according to the route of exposure for different types of nanoparticles, including fullerenes, carbon nanotubes, organic and inorganic nanoparticles, nanocapsules, nanospheres, nanoshells and quantum dots.
Institut de recherche Robert Sauvé en santé et en sécurité du travail (IRSST), 505 boul. de Maisonneuve Ouest, Montreal (Quebec) H3A 3C2, Canada, 2006. iv, 53p. Illus. 144 ref. Price: CAD 7.42. Downloadable version (PDF format) free of charge. [in English]


CIS 07-1344 Barbosa de Alencar J.R.
Occupational hazards during the production of pharmaceuticals: Analysis of an industry located in northeastern Brazil
Riscos ocupacionais na fabricação de medicamentos: análise de uma indústria localizada no Nordeste brasileiro [in Portuguese]
Pharmaceutical production is a complex industrial process that demands high levels of investment in development, production equipment, quality control and staff training. Paradoxically, in spite of being a sector that deals uses modern technology and the requirements of good manufacturing practices (GMP), the pharmaceuticals industry is a source of several risks to workers' health and the environment. This article presents the findings of a study on occupational hazards carried out internally by the safety and health committee of a pharmaceutical company located in northeastern Brazil.
Revista brasileira de saúde ocupacional, 2005, Vol.30, No.112, p.49-67. Illus. 31 ref.

CIS 06-1350 Elliott L., Heederick D., Marshall S., Peden D., Loomis D.
Incidence of allergy and allergy symptoms among workers exposed to laboratory animals
In this study on the relation between exposure to laboratory animals and laboratory animal allergy (LAA), data were obtained by questionnaires and serological tests from a cohort of workers exposed to laboratory animals at a pharmaceutical manufacturing company during a 12-year period. Poisson regression was used to model the incidence rate ratios of LAA at different levels of exposure. Higher incidence rate ratios were seen with increasing reported hours carrying out tasks involving working with animal cages or with many animals at one time. The most common symptoms were related to rhinitis rather than to asthma. This study suggests that the risk of LAA increases with duration of exposure to animals and work in animal related tasks. Incidence might be reduced by limiting hours per week of exposure to laboratory animals.
Occupational and Environmental Medicine, Nov. 2005, Vol.62, No.11, p.766-771. Illus. 19 ref.


CIS 05-338 Zuskin E., Mustajbegovic J., Schachter E.N., Kern J., Deckovic-Vukres V., Pukarin-Cvetkovic J., Nola-Premec I.A.
Respiratory findings in pharmaceutical workers
Pharmaceutical workers may be at risk of developing respiratory problems as a result of their work environment. This study investigated 163 female and 35 male workers employed in a pharmaceutical plant producing primarily antibiotics, in order to characterize the risk of this environment. 113 controls were selected from a food packing facility. Chronic respiratory symptoms were recorded by using the British Medical Research Council questionnaire. Acute symptoms which developed during the work shift were recorded and participants were subjected to spirometry tests. A significantly higher prevalence of chronic respiratory symptoms was recorded among pharmaceutical workers (compared to controls), the highest being for sinusitis, nasal catarrh, and dyspnoea. There was also a high prevalence of acute symptoms recorded during the work shift. The most significant risk factors for these respiratory findings were smoking and length of time worked in the pharmaceutical industry, particularly in men.
American Journal of Industrial Medicine, Nov. 2004, Vol.46, No.5, p.472-479. 26 ref.

CIS 05-346 Medical salesmen - Relationship between health and work
Les visiteurs médicaux - Relations santé travail [in French]
There are more than 20,000 medical salesmen in France. The objective of this cross-sectional epidemiological study was to better understand the risk factors and physical and mental health problems of medical salesmen and to propose practical preventive measures. The study is also of relevance to persons responsible for salespersons in general, including occupational safety and health specialists, in view of the many common aspects that apply to these mobile workers. It was conducted in the form of a self-administered questionnaire returned by 1003 medical salesmen. Interpretation of the questionnaire by occupational physicians focused on the following aspects: hazards during driving; lifestyles and nutrition; stress, anxiety and depression.
Centre Interservices de Santé et de Médecine du travail en Entreprise (CISME), 10, rue de la Rosière - 75015 Paris, France, 2004. 145p. Illus. 45 ref. Price: EUR 17.50 (including VAT).

CIS 04-655 Goyer N., Beaudry C., Bégin D., Bouchard M., Carrier G., Gely O., Gérin M., Lefebvre P., Noisel N., Perrault G.
Impacts of the lowering of the permissible exposure value for formaldehyde - Group 3: Other sectors
Impacts d'un abaissement de la valeur d'exposition admissible au formaldéhyde - Groupe 3: Autres secteurs [in French]
The objective of this study was to assess the number of workers in a variety of industries and sectors in Quebec that would be exposed to excessive formaldehyde concentration levels and the cost of compliance per worker as a function of the various possible threshold limit values under consideration. This specific study was carried out within the framework of a large research programme aimed at evaluating the health and socio-economic impacts of lowering the current maximum permissible exposure value for formaldehyde of 2ppm to one of the values of 1.0, 0.75 or 0.3ppm, either as maximum or 8-hr time-weighted average values. (See also CIS 04-642 to 04-651, CIS 04-653 and CIS 04-654).
Institut de recherche en santé et en sécurité du travail du Québec (IRSST), 505 boul. de Maisonneuve Ouest, Montreal (Quebec) H3A 3C2, Canada, 2004. 97p. 94 ref. Price: CAD 8.56. Downloadable version (PDF format) free of charge. [in French]


CIS 03-1923 Wirtanen G., Salo S.
VTT Technical Research Centre of Finland
34th R3-Nordic contamination control symposium
Proceedings of a conference on contamination control held in Turku, Finland, 2-4 June 2003. Papers are grouped according to the sessions in which they were presented: plenary session on contamination control; contamination control in food processing and biotechnology; contamination control in pharmaceutical processes; contamination control in microelectronics and clean room technology.
VTT Information Service, P.O.Box 2000, 02044 VTT, Finland, 2003. 418p. Illus. Bibl.ref. Price: EUR 85.00 (+ 8% VAT). [in English]

CIS 03-738 Park J., Plese M.R., Puskar M.A.
Evaluation of a personal monitor employing an electrochemical sensor for assessing exposure to hydrogen peroxide in the workplace
The monitoring of vapour phase hydrogen peroxide (VHP) has gained increasing importance in the pharmaceutical industry because sterilization using VHP has proven to be a good alternative to previously used sterilizing methods. The current method based on bubbling air through an acid solution with subsequent laboratory analysis, is not practical for monitoring personal exposures. A commercially-available electrochemical sensor direct-reading instrument designed for personal monitoring of VHP was evaluated in the laboratory and under typical workplace. Time-weighted average concentration data from the direct-reading instrument was compared with concentration data from the existing analytical method. Selected performance characteristics of the instrument also were investigated, including reproducibility, response and recovery times, calibration frequency and suitability of the calibration adapter. Results suggest that the instrument provides a means for simple and accurate monitoring of personal exposures to VHP in workplace environments.
AIHA Journal, May-June 2003, Vol.64, No.3, p.360-367. Illus. 24 ref.


CIS 03-324 Hirst N., Brocklebank M., Ryder M.
Containment systems - A design guide
Manufacturing industries are now producing materials that can have adverse effects on humans or the environment if released even in very small quantities. This is particularly true of the pharmaceutical industry, The term "containment" is used to describe equipment or systems that prevent the release of harmful substances. This publication consists of a practical guide for the design of containment equipment or systems of harmful substances during transfer operations. Contents: containment legislation; occupational hygiene aspects of containment; examples of industrial operations requiring containment; principles for the design of containment systems; development of a containment strategy; types of containment equipment; control of wastes and emissions; operation and maintenance of containment devices; ventilation.
The Institution of Chemical Engineers (IChemE), Davis Building, 165-189 Railway Terrace, Rugby CV21 3HQ, United Kingdom, 2002. v, 199p. Illus. 73 ref. Index. Price: GBP 80.00 (+ VAT).

CIS 02-1932 Goodno L.E., Stave G.M.
Primary and secondary allergies to laboratory animals
Although laboratory animal allergy (LAA) is a significant occupational hazard among workers exposed to laboratory animals, few studies have evaluated long-term risks to workers. In this study, surveillance data from a ten-year LAA prevention programme were analysed to estimate incidence rates of primary and secondary LAA and to evaluate the effectiveness of the prevention programme in reducing the development of primary LAA. The ten-year incidence rates of primary and secondary LAA were 1.34 and 11 cases per 100 person-years, respectively. The annual incidence of primary LAA was reduced from 3.6% to 0% in the first five years and did not rise above 1.2% over the remaining years, whereas the incidence of secondary LAA was greater than 8% in most years. These findings suggest that programmes effective at preventing primary LAA may need to be evaluated for their effectiveness at protecting against further risk.
Journal of Occupational and Environmental Medicine, Dec. 2002, Vol.44, No.12, p.1143-1152. Illus. 30 ref.


CIS 00-1463 Wirtanen G., Salo S., Mikkola A.
30th R3-Nordic Contamination Control Symposium
Proceedings of the annual symposium of R3-Nordic, the association for microbial contamination control held in Helsinki, Finland, 30 May-2 June 1999. Contents: contamination control in food processing; contamination control in pharmaceutical processes; clean room technology and contamination control in microelectronics.
VTT Technical Research Centre of Finland, Espoo, Finland, 1999. 503p. Illus. Bibl.ref.


CIS 01-153 Huyart A., Dimerman S., Lauzier F.
Prevention of toxic risk during the production of pharmaceutical drugs - Conclusions derived from observing the operating practices of six companies
La prévention du risque toxique lié à la fabrication des médicaments: axes de réflexion élaborés à partir de la pratique observée dans six entreprises [in French]
Topics: carcinogenic effects; corticoids; cytostatic drugs; dermatological effects; dosimetry; drugs; eczema; industrial physicians; irritants; limitation of exposure; long-term exposure; myelotoxic effects; oestrogens; pharmaceutical industry; risk factors; toxic effects; toxicology; tranquillizers; vitamins.
Documents pour le médecin du travail, 3th Quarter 1998, No.75, p.231-250. 72 ref.

CIS 99-1564 Lauerma A.I.
Occupational contact sensitization to corticosteroids
Topics: case study; corticoids; eczema; pharmaceutical industry; sensitization dermatitis; skin allergies; skin tests.
Contact Dermatitis, Dec. 1998, Vol.39, No.6, p.328-329. 5 ref.

CIS 99-656 Fisher R., Saunders W.B., Murray S.J., Stave G.M.
Prevention of laboratory animal allergy
A comprehensive programme to reduce exposure to environmental allergens was implemented in a large pharmaceutical company. The programme included education, engineering controls, administrative controls, use of personal protective equipment and medical surveillance. Results of a prospective survey of five years of data showed that the prevalence of laboratory animal allergy ranged from 12% to 22% and that the incidence was reduced to zero during the last two years of observation. Laboratory animal allergy is preventable through the implementation of a comprehensive effort to reduce exposure to allergens. Topics: allergies; experimental animals; health programmes; laboratory work; limitation of exposure; long-term study; medical supervision; pharmaceutical industry; programme evaluation; protective clothing; risk factors; safety training in industry.
Journal of Occupational and Environmental Medicine, July 1998, Vol.40, No.7, p.609-613. 24 ref.

CIS 99-81
Cámara de la Industria Farmacéutica (ANDI)
Programme of epidemiological surveillance of psychosocial risk factors in the pharmaceutical industry
Programa de vigilancia epidemiológica de factores de riesgo psicosocial para el sector farmacéutico [in Spanish]
Topics: conditions of work; health hazards; human behaviour; mental stress; mental workload; neuropsychic stress; pharmaceutical industry; programme evaluation; questionnaire survey; social aspects; stress factors; training manuals; training material.
Seguro Social, Protección Laboral, Administradora de Riesgos Profesionales, Santafé de Bogotá, Colombia, no date. 36p. Illus. 27 ref.


CIS 02-1544 4-Chlorophenyl isocyanate
4-Chlorphenylisocyanat [in German]
Repeated contact with 4-chlorophenyl isocyanate causes itchy erythema and dryness of the skin. The substance irritates the eyes. Animal experiments show high toxicity upon inhalation exposure and harmful to toxic effects upon acute oral and dermal administration. No genotoxic effect has been observed. A comparison of the toxic effects of 4-chlorophenyl isocyanate, phenyl isocyanate and 4-isopropylphenyl isocyanate in humans and animals is also presented. In humans, the only toxic effect described is an itchy erythema after repeated contact with chlorophenyl isocyanate.
Berufsgenossenschaft der chemischen Industrie, Postfach 10 14 80, 69004 Heidelberg, Germany, Jan. 1997. 23p. 20 ref.

CIS 98-730 Muir D.C.F., Verrall A.B., Julian J.A., Millman J.M., Beaudin M.A., Dolovich J.
Occupational sensitization to lactase
Topics: airborne dust; allergic asthma; allergic rhinitis; Canada; enzymes; pharmaceutical industry; sensitization; skin tests.
American Journal of Industrial Medicine, May 1997, Vol. 31, No.5, p.570-571. 3 ref.

CIS 98-727 Wigger-Alberti W., Elsner P.
Occupational contact dermatitis due to pyritinol
Topics: allergy tests; case study; dermatitis; eczema; laboratory work; pharmaceutical industry; pyridine and derivatives; pyridoxine; sensitization dermatitis; skin allergies; Switzerland.
Contact Dermatitis, Aug. 1997, Vol.37, No.2, p.91-92. Illus. 28 ref.

CIS 98-717 Jolanki R., Alanko K., Pfäffli P., Estlander T., Kanerva L.
Occupational allergic contact dermatitis from 5-chloro-1-methyl-4-nitroimidazole
Topics: allergens; allergy tests; azathioprine; case study; dermatitis; eczema; Finland; imidazoles; pharmaceutical industry; sensitization dermatitis; short-term exposure; skin eruption; skin tests; thin-layer chromatography.
Contact Dermatitis, Jan. 1997, Vol.36, No.1, p.53-54. 6 ref.

CIS 97-1552 Process industry
These nine chapters in a major new survey of OSH examine health and safety issues in various process industries: power generation; chemical industry; polymers and rubbers; paint industry; pharmaceutical industry; biotechnology industry; food processing industry; paper, pulp and chloralkali industry; tobacco industry.
In: The Workplace (by Brune D. et al., eds), Scandinavian Science Publisher as, Bakkehaugveien 16, 0873 Oslo, Norway, 1997, Vol.2, p.297-433. Illus. Bibl.ref.


CIS 98-1733 O'Reilly Herrera Y.A., Sanabria Reyes O.
Industrial safety for job satisfaction and the solution of productivity problems
La seguridad industrial como vía para la satisfacción laboral y la solución de problemas productivos [in Spanish]
Topics: design of equipment; ergonomic evaluation; increase in productivity; job study; pharmaceutical industry; repetitive work; safety and productivity; seats and working surfaces; speed of work; workplace design.
Mapfre seguridad, 4th Quarter 1996, No.64, p.3-13. Illus. 8 ref.

CIS 97-1597 Forni A., Bonatti S., Merler E.
Cytogenetic indicators of genotoxicity in subjects occupationally exposed to antineoplastic drugs
Indicatori citogenetici di genotossicità in soggetti professionalmente esposti a chemioterapici antiblastici [in Italian]
Cytogenetic tests most frequently used to detect early biological effects in people exposed to genotoxic agents are reviewed. In particular, chromosome aberrations, sister chromatid exchanges and micronuclei in lymphocytes are discussed. In hospital or industry workers potentially exposed to antineoplastic drugs the results are contradictory. Investigations involving subjects who have worked under protected conditions have however given negative results for these indicators.
Medicina del lavoro, May-June 1996, Vol.87, No.3, p.222-229. 34 ref.

CIS 97-1596 Merler E., Villa L., Lucchini R.
Adverse effects of exposure in the production, handling and administration of antineoplastic drugs
Effetti patologici causati da chemioterapici antiblastici nei lavoratori addetti alla loro produzione, preparazione o somministrazione [in Italian]
Many antineoplastic drugs are carcinogenic or mutagenic in humans. This study concerns the increased risk of cancer for workers handling such drugs. Among women workers there is an increased risk of spontaneous abortions and offspring malformations. This is an important effect, since the majority of health care workers exposed to antineoplastic drugs are women. Adequate protective equipment during the production and administration of these drugs and suitable preventive educational programmes are necessary for these workers.
Medicina del lavoro, May-June 1996, Vol.87, No.3, p.207-221. 42 ref.

CIS 97-1595 Alessio L., et al.
Prevention of risks from occupational exposure to antineoplastic drugs. Consensus document
Prevenzione dei rischi da esposizione professionale a chemoterapici antiblastici. Documento di consenso [in Italian]
This consensus document prepared by Italian research institutes deals with the pathological effects of antineoplastic drugs in patients and occupationally exposed subjects. Preventive measures are discussed, including exposure assessment, health surveillance of workers and guidance for workers' protection (information and training programmes). A particular hazard is that of deformed foetuses, due to the teratogenic effects of these drugs on exposed pregnant women. The importance of preventive measures in the pharmaceutical industry is stressed, in particular those applying to packaging and storage of these products.
Medicina del lavoro, May-June 1996, Vol.87, No.3, p.194-200 (Italian), 201-206 (English).

CIS 97-1572 Górski P., Uliński S.
Effect of occupational exposure to opiates on the respiratory system
The possible mechanisms of the effects of opiates on the respiratory system are reviewed. The known pathophysiology of opiate effects is described, and results of studies on lung function in opiate-exposed workers are summarized. While some cases of bronchial asthma observed in these workers can be explained by the stimulation of opioid receptors in the central nervous system, the possibility of immunological reactions is also possible. Procedures for the diagnosis of opiate-induced asthma are described.
International Journal of Occupational Medicine and Environmental Health, 1996, Vol.9, No.3, p.245-253. Illus. 48 ref.

CIS 96-1756 Fustinoni S., Buratti M., Giampiccolo R., Pulvirenti S., Colombi A.
Biological monitoring of exposure to solvents: A gas chromatography method for the determination of aromatic hydrocarbons in blood and urine
Monitoraggio biologico dell'esposizione a solventi: metodo per la determinazione gascromatografica degli idrocarburi aromatici nel sangue e nell'urina [in Italian]
A gas chromatographic procedure was used for the detection of blood and urinary levels of aromatic hydrocarbons (AH) in 151 workers from three industries: the pharmaceutical industry, photogravure printing and office work. A dynamic head-space purge and trap preconcentration and flame ionization detection were utilized. In the first two categories of the occupationally exposed workers, blood AH levels were of 2-4 orders of magnitude higher than in the environmentally exposed subjects of the third category. In this latter group (office workers) there was a significant difference in blood and urine AH levels between nonsmokers and smokers.
Medicina del lavoro, Jan.-Feb. 1996, Vol.87, No.1, p.63-75. Illus. 18 ref.


CIS 96-2303 Romano C., De Luca G.
Protection of workers exposed to biological agents. Study on the prevention of hepatitis B by means of vaccination in a cohort of such workers. Consideration after a 5-year follow-up
Protezione dei lavoratori dagli agenti biologici. Una esperienza di vaccinoprofilassi contro l'epatite B in una popolazione di professionalmente esposti a rischio. Considerazioni dopo 5 anni di follow-up [in Italian]
The results are reported of a cohort study conducted for 5 years in 82 workers exposed to biological hazards (manipulation of sera in a pharmaceutical plant). The workers were vaccinated at scheduled intervals (three doses) against hepatitis B. The effectiveness of their immunization was repeatedly checked in subsequent years by means of an anti-HBs titre assay. In 96.3% of the subjects the result of the assay was positive (HBsAb >10mUI/mL serum level, i.e. the generally accepted cut-off value for a specific positive response). Only three subjects (3.66%) showed no response. To protect these workers, a further administration of vaccine is proposed by some experts. Booster doses 1-2 months after the third dose of vaccine are suggested for workers with anti-HB titres below 10mUI/mL, in order to prolong their immunity against HBV. Repeated serum controls are recommended for all workers every 4-5 years.
Archivio di Scienze del Lavoro, Jan.-Mar. 1995, Vol.11, No.1, p.17-21. 20 ref.

CIS 96-1719 Chemical industry
Kemisk industri [in Danish]
A systematic summary of publications and documentation regarding working environment factors and the state of workers' health in the Danish chemical industry. About 49,000 people are employed in the industry, of which 1/5 work in the pharmaceutical sector. The main factors are: exposure to chemicals, accidents and strain injuries. Other factors are noise and whole-body vibration. These factors are common throughout the industry, but rubber and pharmaceutical factories, followed by those producing plastic packaging and plastic goods, are the most exposed sectors.
Arbejdstilsynet, At-Salg, Landskronagade 33, 2100 København Ø, Denmark, 1995. 83p. Price: DKK 100.00 + tax.


CIS 96-2158 Marley K.A.
Field performance of a new design of a total inhalable dust sampling head
The performance of an open-faced, total inhalable dust, sampling head incorporating a 13mm dia. filter was compared with the 25mm dia. seven-hole sampling head recommended by the Health and Safety Executive (HSE) for total inhalable dust sampling. Side-by-side static measurements were carried out in a pharmaceutical factory using six sampling heads of each design. The results did not show a significant difference between the performance of the two designs when used as static samplers at low ambient air velocities. The 13mm dia. total inhalable dust sampling head has some practical advantages over the larger 25mm dia. seven-hole sampling head both in use and in worker acceptability. However, further studies are necessary to validate its performance as an inhalable dust sampler.
Annals of Occupational Hygiene, Dec. 1994, Vol.38, No.6, p.895-902. Illus. 11 ref.

CIS 96-685 Hansen J., Olsen J.H., Larsen A.I.
Cancer morbidity among employees in a Danish pharmaceutical plant
The files of 10,889 people ever employed (1964-1988) at the pharmaceutical plant were followed-up in the nationwide Danish Cancer Registry. Site-specific standardized incident ratios (SIR) were estimated, based on cancer rates for the national population. Information on risk factors for breast cancer, e.g. number of children, age at menarche and first delivery, obesity, and non-occupational use of sex hormones was obtained from samples of the female employees, and compared to equivalent variables from the general population. The overall SIR for women was significantly elevated (n=5554; SIR=1.2). Excess risk was particularly seen for breast cancer (n=97; SIR=1.5). The SIR was near unity for men (n=5335); however three men with breast cancer versus 0.4 expected were found. Lifestyle components explained only about one-quarter of the excess female breast cancers.
International Journal of Epidemiology, Oct. 1994, Vol.23, No.5, p.891-898. 26 ref.

CIS 95-1329 Agius R.M., Davison A.G., Hawkins E.R., Newman Taylor A.J.
Occupational asthma in salbutamol process workers
Occupational asthma after exposure to salbutamol in the pharmaceutical industry has not been previously reported. The occurrence of occupational asthma is described in two pharmaceutical process workers who were likely to have inhaled doses appreciably in excess of the therapeutic dose range. The findings do not lead to an unequivocal conclusion on the mechanism of the asthma but it was probably a pharmacological consequence of high exposure.
Occupational and Environmental Medicine, June 1994, Vol.51, No.6, p.397-399. Illus. 12 ref.

CIS 95-575 Hansen J., Olsen J.H.
Cancer morbidity among Danish female pharmacy technicians
This study reports on cancer incidence among Danish female pharmacy assistants and dispensers. Altogether, 8,499 members were identified in the archives of the Association of Danish Pharmacy Technicians and followed through the files of the Danish Cancer Registry (1970-1990); observed figures were compared with those expected on the basis of national cancer incidence rates. The overall standardized incidence ratio (SIR) for cancer was 1.0. A 1.5-fold elevated risk of non-melanoma skin cancer was found, especially for long-term pharmacy assistants. An increased risk for non-Hodgkin's lymphoma appeared among long-term pharmacy dispensers. Sunlight is usually the dominant cause of non-melanoma and melanoma skin cancer, but occupational factors may have contributed in this study in view of the uncommon localization observed for many of these cancers and the unelevated melanoma risk. In addition to the increased risk of non-Hodgkin's lymphomas, which may have been associated with exposure to organic solvents, the results do not indicate any other notable cancer risks during the follow-up.
Scandinavian Journal of Work, Environment and Health, Feb. 1994, Vol.20, No.1, p.22-26. 22 ref.

CIS 94-1972 Sessink P.J.M., Timmersmans J.L., Anzion R.B.M., Bos R.P.
Assessment of occupational exposure of pharmaceutical plant workers to 5-fluorouracil - Determination of α-fluoro-β-alanine in urine
The exposure of pharmaceutical plant workers involved in drug compounding and drug production to 5-fluorouracil (5FU) was studied. 5FU was determined by analysis of air and wipe samples. It was detected in the air (75µg/m3), on the floor (particularly after routine cleaning, up to 630ng/cm2), on persons and on gloves. The uptake of 5FU was established by determination of α-fluoro-β-alanine, the main metabolite of 5FU, in the urine of the workers. Evidence for exposure to 5FU was therefore found.
Journal of Occupational Medicine, Jan. 1994, Vol.36, No.1, p.79-83. Illus. 17 ref.


CIS 95-208
Technischer Überwachungs-Verein Bayern Sachsen e.v. Umwelt und Entwicklung
Safety and health framework for emergency plans in genetic engineering plants
Sicherheitstechnische Rahmenbedingungen für Notfallpläne bei gentechnischen Anlagen [in German]
The facts that need to be taken into account in making emergency plans for genetic engineering plants include: the location of the plant, the number of employees, the type of organisms used, the equipment and buildings, the internal and external hazards such as equipment failure, fire, explosion, human failure, natural disasters that could cause the release of harmful genetically-engineered organisms into the environment, the dispersion of the released organisms in soil, water and the atmosphere and the consequences. Two fictive cases, an explosion in the immediate vicinity of a genetic engineering plant and the explosion of a fermentor inside a genetic engineering plant are used to illustrate measures needed for protection from, or containment of, inadvertent releases.
Bayerisches Staatsministerium für Landesentwicklung und Umweltfragen, Rosenkavalierplatz 2, 81925 München, Germany, June 1993. iii, 235p. Illus. Bibl.ref.

CIS 94-1268 Rêgo M.A.V., Silvany Neto A.M., Macêdo J.S., Sousa C.S.C., Lima M.A.G., Rêgo R.C.F.
Health and work in a pharmaceutical plant
Saúde e trabalho numa indústria farmacêutica [in Portuguese]
Preliminary study of the health problems among workers in a pharmaceutical plant in the state of Bahia (Brazil) and of the occupational factors that might have caused them. A total of 108 workers underwent a medical examination. More than 50% had symptoms of physical tiredness, chest and leg pain, headaches and nervousness. Other symptoms, with incidence rates between 25-50%, included forgetfulness, mental fatigue, itchiness of the eyes, dizziness, arm pain, nasal obstruction and insomnia. Without making any attempts at establishing a relationship between these symptoms and workplace exposure factors, the article describes some of these factors: noise, heat, dust, presence of pharmaceutical substances in the air, repetitive work. Though the plant is relatively new, it is suggested that much more preventive action could be undertaken than has been the case until now.
Revista brasileira de saúde ocupacional, July-Sep. 1993, Vol.21, No.79, p.39-47. 17 ref.

CIS 94-1024
Center for Chemical Process Safety
International process safety management conference and workshop
Papers presented at an international meeting in San Francisco, California, USA (22-24 Sep. 1993) organized by the American Institute of Chemical Engineers, the UK Health and Safety Executive, the US Environmental Protection Agency, the European Federation of Chemical Engineering and the Society of Chemical Engineers, Japan. Some of the 39 submissions discuss general management issues. Others describe the experience of individual countries or multinational companies, specific technical issues or the role of ISO standards.
American Institute of Chemical Engineers, 345 East 47th Street, New York, NY 10017, USA, 1993. viii + 560p. Illus. Bibl.ref. Price: USD 100,00 US and Canada; USD 140,00 elsewhere.

CIS 93-1683 Martynjuk V.F.
Are control rooms dangerous?
Opasny li operatornye? [in Russian]
Accident reports for explosions in the chemical, petroleum refining and biotechnology industries occurring in the Russian Federation in 1990-92 were reviewed to determine their consequences for control-room personnel. Nineteen accidents involved injury to workers (100 victims, many of them repair workers), eight with fatalities (17 victims); injuries were sustained by persons in or near the control room in six cases (22 victims), with fatalities (8) in two of the events. The high proportion of deaths suggests that control-room structures must be reinforced.
Bezopasnost' truda v promyšlennosti, Jan. 1993, No.1, p.14-16.


CIS 94-718 Müller E., Wittig M.
Is chlamydia still an important pathogen to man? A case study
Chlamydien als Infektionserreger für den Menschen noch von Bedeutung? Eine Fallbeschreibung [in German]
A case of interstitial pneumonia was traced to Chlamydia ovis as causative agent. A female patient had worked three weeks before the outbreak of the disease on a temporary basis in a laboratory where chicken eggs were inoculated with Chlamydia ovis for producing a vaccine against the pathogen. Symptoms and treatment are described. A literature survey of known cases of infections with Chlamidiaceae reveals among other things birds and cattle as carriers of the pathogen. The importance of work history, serum diagnosis and chest radiography is stressed.
Arbeitsmedizin - Sozialmedizin - Präventivmedizin, Apr. 1991, Vol.26, No.4, p.153-156. 18 ref.

CIS 93-574 Alday E., Moneo I., Lucena R., Zamorano M.L., Montilla A., Cabezas M.M., López M.J.
Occupational sensitisation in the alkaloid preparation industry (Papaver somniferum)
Sensibilización profesional en la industria de preparación de alcaloides (Papaver somniferum) [in Spanish]
A study on sensitisation to poppy (Papaver somniferum) powder took place in the morphine-extraction section of a pharmaceutical enterprise. Medical examinations, in particular skin, blood and respiratory function tests and radiological examinations, were performed on 29 workers, seven of whom had symptoms of sensitisation. The results of the tests indicated that occupational sensitisation to the antigen under study occurred in individuals with symptoms. It was concluded that the medical examinations carried out were appropriate for the investigation of sensitisation. A description of the industrial processes to obtain alkaloids from the poppy plant is included.
Salud y trabajo, 1991, No.84, p.4-8. Illus. 11 ref.

CIS 92-1542 Todaro A., Nava C.
Allergic disease due to squaric acid dibutyl-ester - Description of two cases in a working environment
La patologia allergica da dibutil-estere dell'acido squarico - Descrizione di due casi in ambiente lavorativo [in Italian]
Case study of an episode of contact dermatitis in four pharmaceutical industry workers. Symptoms regressed after cessation of exposure. Each worker underwent clinical investigations with specific patch tests for the products handled. In two subjects there were positive skin reactions to squaric acid dibutyl-ester, a substance with powerful allergenic action and consequently rarely used on the market. Following elimination of the compound from the production cycle, no further cases of dermal symptoms were reported among the operators.
Medicina del lavoro, May-June 1991, Vol.82, No.3, p.276-279. 8 ref.


CIS 96-217 Clean room safety and health management
Kurīn rūmu no anzen eisei kanri [in Japanese]
Clean rooms are especially important in four sectors of Japanese industry: precision instruments, electronics, food and pharmaceuticals. In addition describing the environmental conditions that must be met for a clean room to meet applicable criteria in Japan and elsewhere, this report explains the physical, chemical and biological hazards due to the clean-room environment and to the processes conducted in clean rooms, presents typical management structures for clean-room operations in the four industrial sectors, summarizes applicable Japanese safety and health regulations and lists hazardous substances and their properties. Annexes list (1) hazardous reactions of substances used in the processes typical of clean rooms, and (2) permissible levels of contaminants in wastes for land fill or disposal at sea.
Japan Industrial Safety and Health Association, 5-35-1 Shiba, Minato-ku, Tokyo 108, Japan, Sep. 1990. 128p. Illus. 36+3 ref.

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