EHS-125 Selection of Personal Protective Equipment (PPE)

5.1 Risk Assessment

Ensure all areas and tasks have had a risk assessment conducted to identify the need for PPE.

5.2 Hierarchy of Controls Wherever possible, the following hierarchy of controls will apply:

– Eliminate the hazard

– Substitute

– Engineering controls

– Administrative controls

– PPE – as a last resort, for special “one-off” tasks, tasks that occur infrequently, tasks where the operator requires a higher level of protection.

5.3 Room Signage and Batch Document Instructions

The following procedure steps may be overridden by room signage and batch document instructions in some instances. Where there is a conflict between these and the details in this procedure confirm the room signage and documentation instructions with the operators in the room and follow the signs and documents instead of the subsequent steps in this SOP. If there is any uncertainty, do not enter the area and seek advice from your EHS colleagues.

5.4 Gloves

All protective gloves should comply with the local safety regulations for “Occupational Protective Gloves”.

Nitrile Gloves will be used when handling solvents (Nitrile gloves are resistant to all solvents handled at the GMP facilities).

Heat Resistant Gloves will be used when removing samples from ovens in the laboratory. Latex Gloves will be used when protection is required from dust and product contamination. Cotton Gloves may be worn under any gloves to protect from allergies to the gloves. Nitrile Gloves are also available to anyone with an allergy or sensitivity.

5.5 Safety Spectacles, Goggles and Face Shields

All eye protection will comply with the local safety regulations for “Eye Protectors for Industrial Applications” and recommended Practices for “Occupational Eye Protection”.

Face Shields will be worn when handling open containers of caustic solutions and acids.

Goggles will be used if there is a danger of splashing or high dust area.

Safety Spectacles will be worn in the laboratory, the operation rooms of the production areas and the inside rooms of the Packaging areas at all times.

Welding Mask will be worn for all welding operations.

Safety Spectacles will be worn for any engineering activities carried out in the workshop – e.g. lathe work, grinding, and metal cutting.

Prescription Safety Spectacles will be provided for all colleagues as required.

5.6 Safety Footwear

All safety footwear will comply with the local safety regulations for “Occupational Protective Footwear”.

– Safety Shoes will be worn for all operational warehouse, engineering, manufacturing and packaging activities.

– Closed Shoes will be worn in the laboratory.

5.7 Protective Clothing

– Protective Clothing will be worn in accordance with GMP as well as safety requirements.

– Laboratory Coats will be worn in the laboratory.

– Tyvek Suits will be worn in any areas where protection from dust is required – e.g. operational areas of Core area, some Engineering tasks.

5.8 Respiratory Protection

All respiratory protection will comply with respective local safety regulations for “Use and Maintenance of Respiratory Protective Devices” and “Respiratory Protective Devices”.

5.9 Hearing Protection

All hearing protection should comply with the local safety regulations for “Acoustics – Hearing Protectors” and “Occupational Noise Management”.

Hearing protection will be worn in any areas where noise levels exceed 85 dB (a) and in areas as determined by regular noise monitoring surveys.

5.10 Cleaning and Maintenance

All non-disposable PPE will be regularly inspected by the operators and replaced if there is any visible damage or wear.

Damaged or worn PPE will not be worn.