Safety and quality are two inseparable components of pharmaceutical manufacture. At every stage throughout the entire product lifecycle there is a degree of risk to both the individual performing the task and the product being manufactured, whether it be while handling raw materials through the process of packaging the finished product. Personal Protective Equipment (PPE) has been shown to mitigate these risks significantly by protecting workers against workplace hazard/dangers, including exposure to chemicals, contamination and cross-contamination.
In this post, we will discuss the importance of personal protective equipment in pharmaceutical manufacturing facilities, the different kinds of PPE available on the market, regulatory requirements for the use of PPE and best practices for using PPE in the workplace.
Examples of PPE include gowns, gloves, face shields, goggles and other specialized garments (sterile/contamination-free work areas). The appropriate selection of PPE is dependent upon the type of material being processed, how the material will be used and the level of risk associated with the use of the materials.
B. Face masks and respirators: Face masks and respirators are to be used to protect against breathing dust, vapors and/or microorganisms.
C. Face shields and goggles: Face shields and goggles are used to protect the user from exposure to splashes of corrosive and irritating materials.
2. Chemical-resistant gloves: Chemical-resistant gloves are used for the cleaning and/or handling of solvents.
Users need to remember to change gloves frequently to avoid cross-contamination.
B. Apron: Used during operations involving cleaning or working with corrosive materials.
C. Lab Coats: Generally, provide protection in non-sterile environments.
B. Safety shoes: Safety foot coverings will prevent you from being stepped on from above and also protect you from being contaminated by chemicals in the environment.
B. Powered Air Purifying Respirators are typically used in high risk situations dealing with dangerous materials.
1. WHO Technical Report Series (TRS) No. 986, Annex 2 – stipulates what type of appropriate clothing must be worn by manufacturing personnel.
2. EU GMP Annex 1 – requires that manufacturing personnel’s clothing and PPE minimize the risk of contaminating products and support the continued achievement of aseptic conditions.
3. FDA 21 CFR Part 211 – requires that manufacturing personnel wear appropriate protective apparel so as to maintain cleanliness and cleanliness control.
4. Indian Schedule M (Drugs and Cosmetics Rules) – requires that PPE will be appropriate for the operations performed.
In addition, each of the guidelines discussed above indicates additional requirements (for procedures) regarding validation, employee training and documentation associated with the use of PPE.
1. Improper use or carelessness - Employees occasionally do not wear PPE simply because of limitations on comfort or time.
2. Improper selection of PPE - Using the wrong type of PPE for a specific job will have a negative impact on the effectiveness of the PPE.
3. Lack of adequate training - Without the proper training employees will have increasing risk for contamination.
4. Supply chain/disruption - Considerable shortages of PPE would create a strain on operations within this industry (as seen in a lot of industries during pandemics).
To ensure ongoing compliance with PPE requirements, the manager must provide rigorous oversight and ongoing training to their employees.
Proper use of PPE will help protect workers from exposure to contaminants/impurities, will help to keep the surrounding environment free from contaminants and will support GMP compliance. GMP compliance will provide patients with confidence in the quality of their pharmaceuticals.
PPE for the pharmaceutical industry is necessary to protect employees from hazardous materials, keep products free from contamination and meet international regulatory requirements.
An effective PPE Program consists of a Risk Assessment, Training to ensure proper usage and regular PPE Audits to ensure that PPE continues to provide a safe work environment and provides quality product. Therefore, PPE is more than just another protective device; it is a reflection of the company's commitment to its employees and to the safety and welfare of its patients.
What is Personal Protective Equipment (PPE)?
PPE or Personal Protective Equipment is clothing or devices worn by workers to safeguard themselves from the various types of hazards they may face while working. Within the pharmaceutical industry, PPE provides protection for both employees and products. Additionally, PPE provides two forms of protection in the pharmaceutical industry where protection for the worker is provided against contaminants (chemical or pathogenic) and, secondarily, prevents the worker from contaminating the product.Examples of PPE include gowns, gloves, face shields, goggles and other specialized garments (sterile/contamination-free work areas). The appropriate selection of PPE is dependent upon the type of material being processed, how the material will be used and the level of risk associated with the use of the materials.
Importance of PPE in the Pharmaceutical Industry
The controls on the pharmaceutical industry are strict because of the high standards that must be maintained to assure the integrity and security of products. Thus, proper use of personal protective equipment (PPE) is of utmost importance for three main reasons:1. Employee Safety
Pharmaceutical workers frequently work with very potent active ingredient, solvents and sterilization agents. These materials have the potential for causing skin irritation, respiratory problems or longer-term health issues if inhaled or absorbed. Therefore, PPE serves as the primary means of protection from possible hazards such as chemical, physical or biological.2. Product Protection
Human contamination during manufacturing in sterile or clean room environments presents one of the highest risks to product sterility. Items such as human hair, skin debris, microorganisms and other potential contaminants can lead to contamination of products. PPE helps to prevent shedding of contaminants into the controlled environment in which products are manufactured.3. Compliance with Regulatory Standards
Since Good Manufacturing Practices require adherence to PPE use at the CDC, FDA and WHO; non-compliance may lead to severe penalties, product recalls or shutdown of operations.4. Prevention of Cross-Contamination
In a facility where you produce multiple products, PPE helps minimize cross-contaminants from one product to the other due to the use of specific clothing and methods for segregating materials from one processing area to another.5. Emergency Protection through PPE
In the event of an accidental spill or leak or equipment failure, PPE provides immediate protection against exposure to accidental materials. Properly designed PPE can be the difference between minor incidents and major injuries.Types of PPE Used in Pharmaceuticals
Different PPE items have specific functions and are selected according to the process or task and associated risk when performing that process. The primary categories include:1. Head and Face Protection
A. Hair covers and bouffant caps: Hair covers and bouffant caps are used to protect the product from the contamination of hair or dandruff.B. Face masks and respirators: Face masks and respirators are to be used to protect against breathing dust, vapors and/or microorganisms.
C. Face shields and goggles: Face shields and goggles are used to protect the user from exposure to splashes of corrosive and irritating materials.
2. Hand Protection
A. Disposable gloves (nitrile or latex): Disposable gloves (nitrile and latex) are used to protect the user from the direct contact with hazardous material.2. Chemical-resistant gloves: Chemical-resistant gloves are used for the cleaning and/or handling of solvents.
Users need to remember to change gloves frequently to avoid cross-contamination.
3. Body Protection
A. Coveralls and Gowns: These are entire body garments used in both sterile and non-sterile areas as a way to prevent contamination.B. Apron: Used during operations involving cleaning or working with corrosive materials.
C. Lab Coats: Generally, provide protection in non-sterile environments.
4. Protection for feet
A. Shoe covers: Shoe coverings make it difficult for dirt and debris to leave a controlled space.B. Safety shoes: Safety foot coverings will prevent you from being stepped on from above and also protect you from being contaminated by chemicals in the environment.
5. Protection for Inhalation
A. N95 surgical masks or respirators are typically used in sterile conditions or when working with flying material that causes an airborne particle.B. Powered Air Purifying Respirators are typically used in high risk situations dealing with dangerous materials.
6. Protection for Hearing
Earmuffs and earplugs are used to protect against permanent damage to a person's hearing in an industrial facility where noise levels are high.PPE Requirements in Different Pharmaceutical Areas
1. Sterile Manufacturing (Aseptic Site)
Personnel at the sterile manufacture area must wear a complete sterile uniform including but not limited to sterile overalls, hoods, masks, goggles, sterile gloves and shoe covers. All PPE must be sterilized before the entering the sterile area and must be put on in a classified area where differential pressure is maintained.2. Non-Sterile Manufacturing
Personnel at the non-sterile manufacturing areas shall wear a lab coat, gloves, cap and mask at a minimum. However, the particular protective equipment that will be required for an individual to wear depends upon the materials being handled.3. Warehouse and Dispensing Area
To handle materials in Warehouse and dispensing locations, gloves, a lab coat and safety shoes are required for workers at these locations. This requirement is in effect to protect against potential exposure to active ingredients and/or cleaning agents.4. Laboratory and R&D
Personnel performing work in the laboratory or R&D area must don chemical resistant gloves and goggles, lab coat. Chemical assays or formulation development is performed in fume hoods or with face shields.Regulatory Guidelines on PPE
Pharmaceutical manufacturers have clear and consistent international regulations regarding personal protective equipment (PPE).1. WHO Technical Report Series (TRS) No. 986, Annex 2 – stipulates what type of appropriate clothing must be worn by manufacturing personnel.
2. EU GMP Annex 1 – requires that manufacturing personnel’s clothing and PPE minimize the risk of contaminating products and support the continued achievement of aseptic conditions.
3. FDA 21 CFR Part 211 – requires that manufacturing personnel wear appropriate protective apparel so as to maintain cleanliness and cleanliness control.
4. Indian Schedule M (Drugs and Cosmetics Rules) – requires that PPE will be appropriate for the operations performed.
In addition, each of the guidelines discussed above indicates additional requirements (for procedures) regarding validation, employee training and documentation associated with the use of PPE.
Best Practices for Effective PPE Management
A structured approach for ensuring effective use of Personal Protective Equipment (PPE) should be developed by each pharmaceutical facility:1. Risk Assessment
Before PPE can be selected for use, it is critical to conduct an assessment of hazards (i.e., chemical, biological and ergonomic) that exist in your facility; identify the types of PPE that are appropriate for the hazards found during this assessment of the applicable PPE standard (OSHA regulations).2. Training and Awareness
All employees need to understand the correct methods for wearing (putting on/taking off) and disposing of used PPE as well as the proper methods of cleaning/sanitizing, maintaining and replacing theirs.3. Gowning Procedures
Gowning procedures should follow a logical flow of direction unidirectionally from the most contaminated area to the most sterile area. The use of mirrors or visual aids may help the employee to understand where they are in their respective gowning procedure and assist in confirming they have donned their PPE correctly.4. Fitting and Workplace Environment
The proper fitting of PPE and the manufacturing of PPE materials for their respective working environments have a direct effect on levels of protection and path to contamination.5. Monitoring and Audit
Regular inspections will assist in determining that all employees are following PPE usage policies/procedures and are compliant with the policies and procedures established by the facility.6. Disposal
Used PPE shall be disposed of in color-coded containers/labeled for disposal per OSHA regulations governing biohazard and chemically-contaminated waste; this includes used gloves.Common Challenges in PPE Implementation
PPE compliance is important but does face some challenges:1. Improper use or carelessness - Employees occasionally do not wear PPE simply because of limitations on comfort or time.
2. Improper selection of PPE - Using the wrong type of PPE for a specific job will have a negative impact on the effectiveness of the PPE.
3. Lack of adequate training - Without the proper training employees will have increasing risk for contamination.
4. Supply chain/disruption - Considerable shortages of PPE would create a strain on operations within this industry (as seen in a lot of industries during pandemics).
To ensure ongoing compliance with PPE requirements, the manager must provide rigorous oversight and ongoing training to their employees.
The Link Between PPE and Product Quality
Pharmaceutical contamination is due to human errors and not enough PPE. The connection of how effective PPE protects patients is both a direct link to patient safety and product efficiency. PPE helps protect your employees and provides a critical part of the quality assurance process.Proper use of PPE will help protect workers from exposure to contaminants/impurities, will help to keep the surrounding environment free from contaminants and will support GMP compliance. GMP compliance will provide patients with confidence in the quality of their pharmaceuticals.
PPE for the pharmaceutical industry is necessary to protect employees from hazardous materials, keep products free from contamination and meet international regulatory requirements.
An effective PPE Program consists of a Risk Assessment, Training to ensure proper usage and regular PPE Audits to ensure that PPE continues to provide a safe work environment and provides quality product. Therefore, PPE is more than just another protective device; it is a reflection of the company's commitment to its employees and to the safety and welfare of its patients.
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