Pharmaceutical Safety

Topics: Occupational safety and health, Personal protective equipment, Pharmaceutical industry Pages: 29 (9433 words) Published: November 6, 2011
Safety Implementations

Table of Contents
3Safe Drug Development Process in Pharmaceutical Companies6 4Pharmaceutical Unit Operation Safety Measures10
4.1Weighing and dispensing10
4.2Charging and discharging10
4.3Liquid separations10
5Biosafety Levels12
5.1Level 112
5.2Level 212
5.3Level 312
5.4Level 413
6Personal Protective Equipment13
6.1What is PPE?13
6.2OSHA Standards14
6.3Types of PPE15
6.3.4Hearing Protection22
6.3.5Hazmat Suit22
7Biological Safety Cabinets25
8Pharmaceutical Cleanroom Classification28
11Case Studies33
11.1Case Study #1: Explosion of Organic Powder33
11.2Case Study #2 – Reactor Grounding36
11.3Case Study #3: West Pharmaceutical38
11.4Case Study #4: Effects of oestrogens on pharmaceutical workers41 12Suggested Improvements44

The following paper encompasses an in depth discussion in the various safety implementations in the pharmaceutical industry. A thorough study of various personnel protective equipment for pharmaceutical personnel was discussed including eyewear, glove wear, hearing protection, and foot protection. As well, the OSHA standards which personal protective equipment adhere to are discussed. The safety features for equipment used in the pharmaceutical industry were discussed. Safety devices implemented to protect the environment from the liquid and solid wastes as well as airborne contaminants are discussed. A number of various case studies outlining deficiencies in safety implementation in the industry are discussed.

The pharmaceutical industry is a very complex one which is comprised of different sectors such as public and private organizations, research and development companies, and hospitals whose responsibility is to discover, research and develop drugs for human and animal health. Because the industry is always changing and new research and innovations are developed as time progresses, this creates a large concern regarding worker safety and health. The Food and Drug Administration (FDA) is the regulatory agency that controls the pharmaceutical facility and equipment design, and ensures worker and consumer safety. In order for a drug to be sold commercially, strict procedures and documentation is needed and implemented in the pharmaceutical facility itself. The FDA then performs an audit ensuring the company followed the strict guidelines, and once passed, they are allowed to commercially produce their drug. Along with the above mentioned guidelines, there are cGMP guidelines (current good manufacturing practice) that are enforced by the FDA as well. There are also numerous equipment safety concerns that one needs to be aware of in pharmaceutical industry. The following report will outline several aspects of safety implementation in the pharmaceutical industry. First will be a general overview of what personal protection is, and what kind of equipment are used in a pharmaceutical facility. FDA regulations will be analyzed in terms of a safety laws that must be followed. The safety hazards of some of the common equipment used in the pharmaceutical industry will also be identified. A literature review will be conducted of a pharmaceutical company’s current safety precautions taken in their facilities. Furthermore, case studies will be analyzed where accidents occurred because of a lack of safety implementation in manufacturing and production of drugs.

3Safe Drug Development Process in Pharmaceutical Companies
Many factors influence the role of pharmaceutical companies on a social level. The activities of pharmaceutical companies are subject to legislation and regulation with regards to drug development and approval, manufacturing and...

Figure 1: Various types of drugs and their effects (OHSA, 2009)
Figure 2: Synthetic process of pharmaceutical development (OHSA, 2009)
Process safety is very complex in such types of drug manufacturing
4.2 Charging and discharging
The charging and discharging of materials are usually done throughout a process where portions of the final product are separated in segments (Stellman, 1998)
4.5 Compounding
During compounding, solids and liquids are mixed to produce solutions, pastes or slurries, depending on the type of application (Stellman, 1998)
4.6 Drying
A batch of active pharmaceutical ingredients (APIs) may be sent to a dryer to remove the water content from it before it can be mixed with an excipient (a filler) to make a dosage tablet (Stellman, 1998)
5.1 Level 1
Level 1 laboratory contains only well-characterized agents which do not cause disease in healthy adult humans and have a minimum potential hazard to personnel and the environment (CDC, 2004)
5.2 Level 2
Level 2 laboratories are similar to Level 1, except they contain agents with a moderate potential hazard to personnel and the environment (CDC, 2004)
5.3 Level 3
Level 3 laboratories are used for clinical and production facilities where work is done with exotic agents which may cause serious or potentially lethal disease after inhalation, but which treatment exists (CDC, 2004)
• Hazmat suits
This list of equipment is not exhaustive, and there a number of other items that are used to increase safety (OSHA, 2009)

Figure 3: Gloves composed of various materials (Canadian Centre for Occupational Health and Safety, 2009)

Table 1: Classes of protection (Canadian Standards Association, 2009)

Figure 4: Standard safety glasses (CCOHS, 2009)
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