1. Bi-Weekly Safety Meeting November 29, 2012 General Environmental, Health, and Safety

2. Awareness Training This session is a general overview of some of the inherent hazards of work in and around a biopharmaceutical and a biotech facility. All employees must receive client specific training prior to entry onto to a client’s facility.

3. What to Expect Clients commitment to Good Manufacturing Practices Summary of lab environments and by- products of vaccine production Production environments; chemicals and equipment Lab animal research and hygiene Chemicals in the process

4. GMP Clients are to follow Good Manufacturing Practices – Ensures quality product – Processes are validated – Written procedures followed – Training provided to prevent contamination – Records of manufacturing and distribution – Quality control maintained – Complaints examined and investigated

5. Lab Environments Laboratory cleanliness shall be observed Requires special training to enter area Protective clothing is worn to… – To protect the product – To protect the employee

6. Lab Environments Hazards include: – Explosions (Reactive chemicals) – Fire (Bunsen burners) – Chemical spills Beware not to walk into a lab with a spill or track a spill Know where the eye wash and chemical spill station is located

7. Live Virus Vaccines utilize – Weakened live virus – Inactive (or killed) virus – Partial virus – Partial bacteria Bloodborne Pathogens… Follow Mangan and the client’s training and control plan on protection against exposure.

8. VOC’s Volatile Organic Compounds – Residual solvents from the manufacturing process – Are emitted as gases – Concentrations of many VOC’s consistently higher indoors (up to 10 times higher) than outdoors – Include a variety of chemicals Short or long term adverse health affects Testing equipment is used to verify the presence of VOC’s

9. Mold as a Byproduct Known to aggravate Asthma Allergic rhinitis – A group of symptoms affecting the nose Hypersensitivity pneuonitis – Inflammation of the lungs due to breathing in a foreign substance, usually certain types of dust, fungus, or molds Penicillin allergies – There is no known relationship between allergy to the mold Penicillium and allergy to the antibiotic penicillin, which is made from the mold. – Airborne exposure can occur. Know the exposure. Check with your doctor if you are allergic to Penicillin.

10. Toxicology in Production Mamillian – Chinese hamster ovary (CHO) cells are the most widely used mammalian cells for transfection, expression, and large-scale recombinant protein production. Macrobial – Yeast and bacteria

11. Clean in Place (CIP) This process is based on the cleaning kinetics of time, temperature, and chemical concentration. Cleaners – Potassium Hydroxide and Sodium Hydroxide Acids – Phosphoric Acid, Acetic Acid, and Citric Acid

12. Lab Animal Research Predominant health risk consideration is for product. Personnel must: – Wear protective apparel – Practice good sanitation and health habits – Be authorized to enter animal research area – Be free from illness and open lesions Can you share any examples of situations where personnel were ill and entered this type of environment?

13. Chemical Products in the Process Ethanol (Alcohol) – Solvent used in manufacturing Cyanide – Off product of the production process Hydrogen Reactors – Used for production of dry products (pills)  Always review the MSDS for chemicals you may come in contact with.  Include the review in your project Job Safety Analysis (JSA).

14. FDA Warning Letters It is common place for the FDA to inspect and even cite manufacturers for not adhering to the regulations. An example is included here: – Employees working in the sterile manufacturing area and sterility suite lack appropriate training in aseptic techniques and aseptic conduct. – In addition, these employees have failed to follow established SOPS designed to prevent microbiological contamination of drug products purported to be sterile as evidenced by FDA’s numerous inspectional observations. – The inspectional observations include an employee entering the Class [redacted] filling suite with exposed skin between the hood and mask.

15. In Summary Follow the GMP Guidelines and client specific training Remain aware of your environment and the chemical and biological exposures – Review the MSDS prior to work Don the proper PPE to protect yourself and the product Practice good hygiene

16. QUESTIONS? COMMENTS? Please e-mail safetytraining@manganinc.com safetytraining@manganinc.com