Maintaining adequate PPE guidelines helps to control pharmaceutical contamination and ensure safety of the personnel as well as critical products and processes 

In the pharmaceutical industry, hygiene and safety are considered two most important aspects. Personnel directly involved with the manufacturing and handling of pharmaceutical products are constantly exposed to chemical and biological hazards. Furthermore, they regularly come to contact with aerosol formation, liquids, dust and particles – all of which can result into significant health implications if adequate preventive measures are not implemented.

Not practicing optimal hygiene and safety standards can also lead to pharmaceutical contamination, having significant consequences on the product quality, your business sustenance and public safety at large. To ensure safety of your workers, maintain hygiene and control contamination, it is imperative to regulate use of Personal Protective Equipment (PPE) inside the facility.

What is Personal Protective Equipment?

 Personal Protective Equipment (PPE) is a protective gear that is designed to facilitate improved health and safety of workers in the pharmaceutical industry, reducing direct exposure to chemical or biological agents. PPEs include items such as high-visibility workwear clothing, eye protective gears, safety helmets, safety harnesses, hazmat suits, ear defenders or ear plugs, and respiratory protective equipment.

However, there are certain limitations to using PPE. These must be assessed to set clear and effective guidelines for using Personal Protective Equipment in the pharmaceutical industry. The risks involved are:

  • Maximum levels of safety are rarely achieved with PPE due to factors like poor fit, inadequate cleaning, and failure to wear when necessary
  • PPE might restrict the worker’s visibility or mobility, and become an extra weight to be handled
  • Using PPE may change the personnel’s attitude towards the hazards

Guidelines for Using Personal Protective Equipment in the Pharmaceutical Industry

 Discussed here are the definitive guidelines pharmaceutical companies should implement to regulate and control use of PPEs inside the facility or handling the products directly.

 

  1. Choose the Right Personal Protective Equipment

PPE not only helps protect the personnel from dust, hazardous chemicals or other toxic substances, but also prevents human contamination. Therefore, choosing the right PPE is critical:

  • Depending on the application, pick the appropriate material for the PPE. There are commonly three types of materials: spun bond – melt blown – spun bond (SMS), microporous film (MPF), and Tyvek. Consider the specifications and tensile strength of each material to choose one that fits your requirements.
  • Perform rigorous testing and risk assessment to ensure the PPE provides maximum protection against chemical or biological hazards, dust and particles. It should also provide the lowest levels of inward leakage.
  • Perfect fit and comfort are two important factors you should consider when choosing the right PPE for your personnel. Since the workers are required to wear it the entire time, it must be comfortable. It should allow more flexibility and better movement, without affecting their safety. The fabric should be breathable and resilient. At the same time, the PPE must perfectly fit the wearer to ensure high levels of safety and prevent contamination through human transmission. If the PPE does not fit properly, it can compromise with the worker’s productivity and protection. The cuffs should be tightly sealed. The PPE must be closed at the front and have long sleeves with liquid-tight in the front and at the arms. 

     2. Training on Proper Use of PPE

It is the role of the supervisor to thoroughly train the employees regarding the use of PPE. In case PPC requirements change, re-training should be done. The following guidelines must be followed for training:

  • The right type of PPE and when to use it
  • Limitations of using Personal Protective Equipment
  • How to put the PPE on, adjust it or take it off
  • Manufacturer warnings or instructions if any
  • Maintenance, cleanliness and inspection
  • Ensuring perfect fit and comfort of the PPE
  • How to dispose off a PPE

Proper training and regulating implementation is the key to successful PPE use in the pharmaceutical industry.

        3. PPE Cleaning, Decontamination & Disposal

Adequate guidelines must be implemented to ensure optimum cleaning, disinfection and disposal of pharmaceutical PPEs. Effective cleaning and sanitisation of workwear is important to ensure more safety as well as control contamination from it. Every PPE comes with a lifetime and must be disposed off without further usage. 

      4. Documentation

The following documentation must be maintained regarding PPE risk assessment, selection, training and implementation:

  • Identified hazards and process, activity or job being assessed
  • PPE type, model and brand
  • Personnel and job title who must use PPE
  • Name, title and training date for all workers supposed to wear PPE

 

Conclusion

 Following the above guidelines is critical to successful use of PPE and ensuring improved safety in the pharmaceutical industry.

Lindstrom is a trusted provider of a vast selection of personal protective equipment and workwear rental services in India. We support pharmaceutical companies in maintaining high standards of hygiene and safety, while complying with statutory regulations. Our cleanroom services further ensure that the PPEs are maintained in hygienic facilities to prevent contamination and ensure complete safety.