safety training

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CS-000-AR-016 Preparation of Chemical Solutions Training Module for Filling personnel

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CS-000-AR-016 Preparation of Chemical Solutions Objectives Read and review procedure Define responsibilities Know in detail the proper,safe handling and preparation of chemical solutions. Identify chemical properties Correctly answer assessment questions

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CS-000-AR-016 Preparation of Chemical Solutions Purpose To establish guidelines for the proper and safe handling/preparation of chemical solutions used in the production of plasma products and the cleaning/sanitization of equipment and facilities associated with the production of plasma products.

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CS-000-AR-016 Preparation of Chemical Solutions SCOPE Outline in detail the safe handling and preparation of chemical solutions used throughout the Clayton facility. Does not include analytical or testing equipment and associated areas.

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CS-000-AR-016 Preparation of Chemical Solutions Responsibility Each individual will be trained per this procedure with regards to safe handling and preparation of chemical solutions associated with their areas of responsibility. After training, individuals will assume responsibility for all safety regulations,methods and techniques while handling raw chemicals and preparing chemical solutions.

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CS-000-AR-016 Preparation of Chemical Solutions Definitions Acid: - chemical compound containing hydrogen that forms a salt when combined with a base. Dissolves in WFI and has a pH of less than 7.0 Base: - chemical compound capable of reacting with an acid to form a salt. Typically dissolves in WFI and has a pH greater than 7.0. Solvent: - liquid substance capable of dissolving or dispersing other substances.

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CS-000-AR-016 Preparation of Chemical Solutions Definitions CIP-100: - alkaline (base) detergent formulated for unique cleaning demands of controlled environments. CIP-300: - phosphate free, neutral pH (7.0) liquid detergent used to clean stainless steel and other plasma processing equipment. CIP Additive: - detergent additive used to boost cleaning ability of alkaline or acidic cleaners. Used for manually cleaning small equipment. Phosphate free, mild odor and slightly yellow in color.

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CS-000-AR-016 Preparation of Chemical Solutions Definitions SDA-3A:(solvent) - Industrial grade alcohol usually @ 70-90% IPA:(solvent) - Isopropyl Alcohol Spor-Klenz:(acid) - ready to use sterilant or high level disinfectant for clean room surfaces and equipment. Consists of peracetic acid, hydrogen peroxide and acetic acid.

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CS-000-AR-016 Preparation of Chemical Solutions Definitions ZEP Micronex:(solvent, acid, base) - listed as a cleaner, disinfectant and deodorizer used to clean and disinfect mainly surfaces (ceilings, walls, floors). Not used to clean equipment that may have contact with product. Exothermic reaction: - chemical reaction that results in the generation or release of heat.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Bases - STRONG BASES ARE EXTREMEMLY CORROSIVE TO BODY TISSUE! AVOID ANY CONTACT WITH THE DRY SOLID OR A SOLUTION. - ANY CONTACT WITH THE SKIN OR EYES MUST BE FLUSHED CONTINUOUSLY FOR NLT 15 MIN. AND THEN SEEK MEDICAL ATTENTION. - REPORT ALL INCIDENTS OF CONTACT - IF INHALED OR SWALLOWED, SEEK MEDICAL ATTENTION IMMEDIATELY!

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Bases - USE THE SAME CAUTIONS WHEN DISCARDING. YOU SHOULD ALWAYS TRY TO DILUTE WITH AWFI WHILE DISCARDING IF POSSIBLE. - BASES ARE VERY SLIPPERY. USE EXTREME CAUTION WHEN WALKING IN AN AREA WHEN FLOOR IS WET WITH SOLUTION. - MOST BASES PRODUCE AN EXOTHERMIC REACTION WHEN MIXED WITH WFI. NEVER PREPARE A BASE SOLUTION WITH HWFI.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Bases - PPE for handling and applications: Rubber Gloves Apron…TYVEK, Neoprene, Rubber Safety goggles Face shield Other PPE may be required as deemed necessary by departmental policy.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Acids - ACIDS ARE EXTREMEMLY CORROSIVE TO BODY TISSUE! AVOID ANY CONTACT WITH FUMES OR SOLUTIONS OF ACID. - ANY CONTACT WITH THE SKIN OR EYES MUST BE FLUSHED CONTINUOUSLY FOR NLT 15 MIN. AND THEN SEEK MEDICAL ATTENTION. - CONTACT WITH FUMES CAN RESULTS IN A BURNING SENSATION IN THE EYES, NOSE, OR THROAT. - REPORT ALL INCIDENTS OF CONTACT

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Acids - IF INHALED OR SWALLOWED, SEEK MEDICAL ATTENTION IMMEDIATELY! - ALWAYS USE IN A WELL VENTILATED AREA OR A FUME HOOD WHEN PREPARING. - IF EXCESS FUMES ARE PRESENT THEN A RESPIRATOR IS REQUIRED. - ACIDS PRODUCE AN EXOTHERMIC REACTION WHEN MIXED WITH WFI. NEVER PREPARE AN ACID SOLUTION WITH HWFI. - ACID SPILLS CAN BE SERIOUS AND SHOULD BE HANDLED BY TRAINED PERSONNEL. CALL 3911

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Acids - PPE for handling and applications: Rubber Gloves Apron…TYVEK, Neoprene, Rubber Safety goggles Face shield Fume hoods Respirators (as required) Other PPE may be required as deemed necessary by departmental policy.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Solvents - SOLVENTS ARE HIGHLY FLAMMABLE! KEEP AWAY FROM SOURCES OF IGNITION. - STORE PROPERLY IN TIGHTLY CLOSED CONTAINERS AND IN WELL VENTILATED AREAS. USE FLAMMABLE STORAGE CABINETS AS REQUIRED. - SOLVENTS MAY BE IRRITATING TO THE RESPIRATORY SYSTEM, EYES AND SKIN. TAKE NECESSARY PRECAUTIONS TO PREVENT BODILY CONTACT.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Solvents - IF CONTACT WITH EYES FLUSH CONTINUOUSLY FOR NLT 15 MIN. AND THEN SEEK MEDICAL ATTENTION. - INHALATION OR INGESTION MAY PRODUCE CENTRAL NERVOUS SYSTEM DEPRESSION. USE SOLVENTS IN A WELL VENTILATED AREA. - SPILLS SHOULD BE DILUTED WITH WFI AND DRAINS THOUROGHLY FLUSHED WITH WFI TO RAISE THE FLASH POINT. - ALWAYS DISCARD SOLVENTS TO A GROUNDED CONTAINER.

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CS-000-AR-016 Preparation of Chemical Solutions Safety Precautions for Solvents - PPE for handling and applications: Rubber Gloves Safety goggles Face shield Other PPE may be required as deemed necessary by departmental policy.

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CS-000-AR-016 Preparation of Chemical Solutions Verify all containers used in the preparation are thoroughly cleaned and rinsed. Be sure to measure chemical and water quantities accurately to assure proper formulas and concentrations. Discard remaining solutions after use if not assigned an expiration per procedure. All solutions must be labeled and documented as stated in this procedure and specific cleaning or processing procedures. General Requirements

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CS-000-AR-016 Preparation of Chemical Solutions Acquire appropriate PPE and don correctly Locate and verify chemicals to be used - verify chemical name and number - verify expiration date - review HMIS label and MSDS if necessary Use clean adequate measuring tools, mixers and holding containers Always use AWFI when available Preparing Solutions

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CS-000-AR-016 Preparation of Chemical Solutions Measure majority of final volume of WFI as allowable. Always add chemical to WFI and stir slowly to avoid splashing or spilling. QS to final volume as needed Clean up any spills, complete documentation, label solutions and store chemical in a safe manner. Preparing Solutions

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CS-000-AR-016 Preparation of Chemical Solutions What are the three main categories of chemicals that were discussed in this training? What category would 70% IPA be listed under? True or False? A base solution will typically have a pH of less than 7.0. What category of chemical is Spor-Klenz listed under? Let’s Review

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CS-000-AR-016 Preparation of Chemical Solutions If a chemical makes contact with your skin or eyes what should you do? True or False? A liquid substance capable of dissolving or dispersing other substances is in the category of acids, which includes Spor-Klenz. A chemical reaction that results in the generation or release of heat is known as what? Let’s Review

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CS-000-AR-016 Preparation of Chemical Solutions Name three items of PPE necessary for preparing and handling a solution with a pH lower than 7.0. True or False? If all of a chemical solution is used in a shift, it is not necessary to label the container it was prepared in. List three hazards associated when preparing and handling acids. What are two safe steps when preparing chemical solutions? Let’s Review