Course:SPPH381B/TermProject/Tylenol -Alex Kitt/Blending of Tylenol Ingredients

From UBC Wiki

Blending of Tylenol® Ingredients

Once all of the ingredients have been produced and milled, they need to be combined into the final product. Although blending is a relatively simple step, there is a lot of variability between drugs. Materials and particle sizes must be carefully selected for the final product, as well as blender type and speed and duration of blending in order to produce a homogenous pill [1],[2].

Hazards

Physical

Dust particulates: Due to the milling and blending processes of powdered substances, workers may be exposed to dusts if the ingredients are not properly maintained, leading to a number of health issues. For more information on dust particulates as a hazard see here.

Fire: Tylenol® contains many organic materials which are combustible at high temperature (see Table 1). Additionally, as the ingredients are milled into fine powders, there is an increased risk of fire due to the combustible dusts [3] . Between 1980 and 2005, there were 281 fires caused by combustible dust, killing 119 workers and injuring 718 more [4].

Noise: Potentially high level of noise generated by the ventilation system [1].

Chemical

Exposure to potentially toxic chemicals: some chemicals used in the final Tylenol® product are irritating and hazardous, as seen in Table 1 below:

Chemical MSDS [5] Exposure Limit
Acetaminophen “Slightly hazardous incase of skin and eye contact, ingestion, or inhalation. Maybe combustible at high temperatures.” OEL = 3.0 (mg/m3 8-hour TWA)
Carnauba Wax Very hazardous when ingested, only slightly hazardous in case of eye contact or inhalation. “Maybe combustible at high temperatures.” Not established
Cellulose [6] “Slightly hazardous in case of eye contact (irritant), of ingestion, of inhalation […] May be combustible at high temperature.” OSHA PEL

TWA = 15 mg/m3 (total) TWA = 5 mg/m3 (resp)

Corn Starch [7] “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation [...]May be combustible at high temperature.” OSHA PEL

TWA = 15 mg/m3 (total) TWA = 5 mg/m3 (resp)

FD&C red no.40 “Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature. Not available
FD&C yellow no. 6 “Hazardous in case of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant). May be combustible at high temperature.” Not available
Hypromellose “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” TWA: 10 (mg/m3) (No OSHA value)
Iron oxide black [8] “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), Non-irritant for lungs. The substance is toxic to lungs, upper respiratory tract. Repeated or prolonged exposure to the substance can produce target organs damage.

Non-flammable” || OSHA PEL TWA =10 mg/m3

Polyethylene glycol “Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” None
Polysorbate 80 “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” Not available
Povidone “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” Not available
Sodium starch glycolate “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation. May be combustible at high temperature.” Not available
Stearic acid “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” TWA: 10 mg/m3 from ACGIH (TLV)
Sucralose “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. May be combustible at high temperature.” OSHA (PEL) = 15 (mg/m3)
Titanium dioxide [9] “Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Mutagenic for mammalian somatic cells. IARC level A4 (Not classifiable for human or animal.) Non-flammable.” OSHA PEL TWA

=10 mg/m3

Biological

Due to the stringent requirements in producing pharmaceutical drugs, it is not common for there to be biological hazards. However, one Tylenol factory was shutdown when an FDA inspection discovered the bacterial strain B. copacia [10].


Ergonomic

Repetitive motion: Workers are likely to perform similar tasks (e.g. adding certain ingredients), which can cause strain over prolonged periods. Of the reported injuries at Pfizer and GSK, ergonomic-related injuries are very common, often relating to menial tasks such as pipetting or scooping materials [11].

Potentially heavy lifting: Loading and unloading the blending apparatus (if manual) involves moving heavy loads

Mechanical

Exposed moving machine parts: Any parts of machines involved in milling that move could potentially strike employers causing injury, which is exacerbated by frequent interactions by employees with machines and crowded workplaces [1].

References

  1. ↑ 1.0 1.1 1.2 International Labor Organization. (2011, October 27). Pharmaceutical Industry. Retrieved from http://www.iloencyclopaedia.org/part-xii-57503/pharmaceutical-industry
  2. ↑ De Palma, A. Pharmaceutical Manufacturers. (2005). Powder Blending From Art to Science. Retrieved from http://www.pharmamanufacturing.com/articles/2005/268/
  3. ↑ Canadian Centre for Occupational Health and Safety. (2017). Combustible Dust. Retrieved from https://www.ccohs.ca/oshanswers/chemicals/combustible_dust.html
  4. ↑ Wigmore, D. (2009). Pharmaceuticals Manufacturing: What do we know about the occupational health and safety hazards for women working in the industry? Retrieved from http://www.whp-apsf.ca/pdf/Pharmaceutical%20Manufacturing-%20Health%20%20Safety%20_2_.pdf
  5. ↑ ScienceLab. (n.d.) Material Safety Datasheet Listing. Retrieved from https://www.sciencelab.com/msdsList.php
  6. ↑ The National Institute for Occupational Safety and Health. (2016). Cellulose. Retrieved from https://www.cdc.gov/niosh/npg/npgd0110.html
  7. ↑ Pfizer. (2010). Material Safety Data Sheet Gabapentin Tablets. Retrieved from http://www.pfizer.com/system/files/products/material_safety_data/PZ01158.pdf
  8. ↑ The National Institute for Occupational Safety and Health. (2016). Iron oxide dust and fume (Fe). Retrieved from https://www.cdc.gov/niosh/npg/npgd0344.html
  9. ↑ The National Institute for Occupational Safety and Health. (2016). Appendix G: 1989 Air Contaminants Update Project - Exposure Limits NOT in Effect. Retrieved from https://www.cdc.gov/niosh/npg/nengapdxg.html
  10. ↑ Kavilanz, P. CNN Money. (2010). 'Shocking' conditions at Tylenol plant. Retrieved from http://money.cnn.com/2010/05/14/news/companies/tylenol_recall_plant_conditions/
  11. ↑ Wigmore, D. (2009). Pharmaceuticals Manufacturing: What do we know about the occupational health and safety hazards for women working in the industry? Retrieved from http://www.whp-apsf.ca/pdf/Pharmaceutical%20Manufacturing-%20Health%20%20Safety%20_2_.pdf
Retrieved from "https://wiki.ubc.ca/index.php?title=Course:SPPH381B/TermProject/Tylenol_-Alex_Kitt/Blending_of_Tylenol_Ingredients&oldid=447405"