Pharmaceutical Safety

Safety Implementations

Table of Contents
1 Abstract 4
2 Introduction 5
3 Safe Drug Development Process in Pharmaceutical Companies 6
4 Pharmaceutical Unit Operation Safety Measures 10
4.1 Weighing and dispensing 10
4.2 Charging and discharging 10
4.3 Liquid separations 10
4.4 Filtration 11
4.5 Compounding 11
4.6 Drying 11
5 Biosafety Levels 12
5.1 Level 1 12
5.2 Level 2 12
5.3 Level 3 12
5.4 Level 4 13
6 Personal Protective Equipment 13
6.1 What is PPE? 13
6.2 OSHA Standards 14
6.3 Types of PPE 15
6.3.1 Gloves 16
6.3.2 Footwear 18
6.3.3 Eyewear 20
6.3.4 Hearing Protection 22
6.3.5 Hazmat Suit 22
7 Biological Safety Cabinets 25
8 Pharmaceutical Cleanroom Classification 28
9 Gowning 29
10 Autoclave 31
11 Case Studies 33
11.1 Case Study #1: Explosion of Organic Powder 33
11.2 Case Study #2 – Reactor Grounding 36
11.3 Case Study #3: West Pharmaceutical 38
11.4 Case Study #4: Effects of oestrogens on pharmaceutical workers 41
12 Suggested Improvements 44
13 Conclusions 46
14 Articles 46
15 References 47

1 Abstract
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.

2 Introduction 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

References: 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)