PST NTA Level 6

NTA Level 6 • Semester 1 • PST06103 Quality Assurance and Quality Control Pharmaceutical Production • Source Session/Topic 21 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 21: Quality Assurance and Quality Control Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain quality assurance in pharmaceutical manufacturing • Explain quality control in pharmaceutical manufacturing • Differentiate between quality assurance and quality control • Explain quality variations in pharmaceutical manufacturing • Define documentation in pharmaceutical manufacturing • List documents required for pharmaceutical manufacturing • Explain the importance of documentation in pharmaceutical manufacturing Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer • Handout 21.1: Raw Material Quality Assurance Monograph SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |20 minutes |Presentation |Quality Assurance in Pharmaceutical | | | | |Production | |3 |15 minutes |Presentation |Quality Control in Pharmaceutical | | | | |Production | |4 |10 minutes |Presentation |Difference between QA and QC | |5 |30 minutes |Presentation |Quality Variation in Pharmaceutical | | | | |Production | |6 |30 minutes |Presentation |Documentation in Pharmaceutical | | | | |Production | |7 |05 minutes |Presentation |Key Points | |8 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Quality Assurance in Pharmaceutical Production (20 minutes) • Quality is the totality of features and characteristics of a medicinal product and its ability to satisfy stated and/ or implied needs o Quality begins with research and development o Quality is designed and built in the product • Quality assurance (QA) is a wide ranging concept covering all matters that individually or collectively influence the quality of a product • QA is a totality of the arrangements to ensure that the drug is continuously of the right quality for the intended use • Quality assurance is a part of quality management focused on providing confidence that quality requirements will be fulfilled • Quality Assurance incorporates GMP (which incorporates QC) and also includes product design and development with special focus on process design o GMP is a part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use o Quality relationships in a pharmaceutical industry is; Quality Management Quality Assurance Good Manufacturing Practice (GMP) Quality Control • Elements of Quality Assurance circle in Pharmaceutical Manufacturing; o Research o Development o Prototyping o Documentation o Raw materials o Facilities (buildings) o Equipment o Personnel and supervision o Monitoring, feedback, follow-up • Features of a good QA system; o It is a process, not an end point o It must be independent of financial pressures o Must ensure that quality policies are followed o Must have final authority in product acceptance, rejection and release to public o Must be an integral part in production o Must be responsible for day-to-day operations and for longer term goal settings • Responsibilities of QA include the following; o QA department is responsible for ensuring that the quality policies adopted by the company are followed o Helps to identify and prepare the necessary SOPs relative to the control of quality ▪ Ensures that SOPs are prepared, approved, used and updated o It must determine that the products meet all the applicable specifications and that it was manufactured according to the internal standards of GMP o QA is responsible for quality monitoring or audit function o QA functions to assess operations continually and to advise and guide them towards full compliance with all applicable internal and external regulations o Ensures that proper documentation is followed ▪ Documents are systematic and well kept ▪ Quality manuals are made and staff trained and motivated to comply • Primary functions of QA o Quality control (analytical testing of products) o Raw materials control (sampling, inspecting and testing of incoming raw materials) o Packaging and labelling components (bottles, foils, labels, measures, cartons) o Physical inspection of product and operations at critical intermediate stages ▪ In-process quality control ▪ Batch review ▪ Batch release o Management of internal audit system o Handle customers’ feedback and satisfaction o Management of deviations, incidents and investigations o Management of GMP training system o Management of validation system STEP 3: Quality Control in Pharmaceutical Production (15 minutes) • Quality control (QC) is a component of GMP concerned with sampling, specification and testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality • QC is a part of quality management focused on fulfilling quality requirements • Responsibilities of QC o QC department is responsible for day-to-day control of quality within the company o QC plays major role in selection of qualified vendors from whom raw materials are purchased ▪ Tests representative samples as required ▪ Audit vendor’s operations to determine suitability of the vendor and degree of compliance with GMPs prior to being approved o QC is responsible for analytical testing of incoming raw materials (e.g. assay, titrations etc) o QC is responsible for analytical testing and inspection of packaging components, including labelling (e.g. appearance, spectroscopy, loss on drying etc) o QC is responsible for conducting in-process testing when required, perform environmental monitoring, and inspect operations for compliance o QC is responsible for conducting required tests on finished products or dosage forms (e.g. assay, dissolution, content uniformity etc) o Environmental areas for manufacturing of various dosage forms are tested and inspected by QC department o Generally QC is responsible for efficacy, safety,

NTA Level 6 • Semester 1 • PST06103 In-process Quality Control (IPQC) Pharmaceutical Production • Source Session/Topic 22 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 22: In-process Quality Control (IPQC) Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the concept of in-process quality control • List tests and equipment/apparatus used for in-process quality control of tablets and capsules • Explain the consequences of in-process quality control of tablets and capsules • List the objectives of in-process quality control Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |25 minutes |Buzzing |The Concept of In-process Quality | | | |Presentation |Control | |3 |20 Minutes |Presentation |Objectives of In-process Quality | | | | |Control | |4 |55 Minutes |Presentation |In-process Quality Control Tests in | | | | |the Manufacture of Tablets and | | | | |Capsules | |5 |05 minutes |Presentation |Key Points | |6 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: The Concept of In-process Quality Control (25 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What is in-process quality control? | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • In-process quality control is a type of quality control that provides accurate specific and definite description of procedure to be employed from the receipt of raw material to the release of the finished product • In-process quality control performs checks during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications • In-process quality controls are usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product • Generally, the in-process control procedures are usually rapid and simple tests or inspections that are performed when the manufacturing of a product batch is in progress STEP 3: Objectives of In-process Quality Control (20 minutes) • Some of the objectives of in-process quality control are; o To minimize human errors o To provide accurate, specific and definite description of the procedure to be employed in manufacturing of a product o To detect errors if and when they occur o To pin point responsibility to the personnel involved in the operation of the entire process o To ensure that the flow of manufacturing and packing operations according to established routes and practice is rigidly followed o To detect abnormality immediately and at the same time indicate action needed to correct the problem STEP 4: In-process Quality Control Tests in the Manufacture of Tablets and Capsules (55 minutes) • Evaluation of dosage forms (tablets); o General appearance ▪ Size, shape and texture ▪ Unique identification markings (embossing, engraving or printing) ▪ Organoleptic properties (e.g. colour distribution, taste, odour) o Content uniformity test ▪ 30 tablets are kept aside (sampled), 10 tablets are assayed, 9 tablets should have percentage limit of 85-115% ▪ If more than 1 tablet has 85-115%, then, 20 tablets are assayed and not more than 1 tablet should have 75-125% o Tablet hardness test or tablet crushing strength ▪ Hardness of a tablet is the force required to break a tablet in a diametric compression test ▪ Hardness testing is a laboratory technique used to test the breaking point and structural integrity of tablet under conditions of storage, transportation, and handling before usage (breaking point of a tablet is based on its shape) ▪ Tablet hardness is tested by using Tablet Hardness Tester e.g. Monstanto hardness tester, Stokes harness tester, Erweka tester, Schleuniger or heberlein tester, Strong Cobb tester and Pfizer hardness tester ▪ Conventional tablet hardness: 2.5 – 5 kg/cm2 ▪ Dispersible/chewable tablet hardness: 2.25 -2.5 kg/cm2 ▪ Extended release tablets hardness: 5-7.5 kg/cm2 o Friability ▪ Friability is the tendency of tablets to powder chip or fragment. This affects the elegant appearance of tablets and consumer acceptance of the tablets ▪ Friability leads to variation in the weight and content of tablets ▪ Friability is related to hardness of a tablet ▪ Instrument used for friability testing is known as Friabilator (e.g. Roche friabilator) ▪ Consisting of a plastic chamber that revolves at 25 rpm dropping the tablets through a distance of 6 inches in the friabilator, which is then operated for 100 revolutions ▪ From the friabilator, the tablets are reweighed ▪ Loss in weight is determined ▪ Allowable range is 0.5 – 1.0% o Weight variation ▪ 20 tablets are taken (sampled) and weighed individually ▪ Average weight of the 20 tablets is determined ▪ Weight of individual tablet is compared to the average weight ▪ Not more than 2 of the individual tablet weights deviate from the average weight by more than the prescribed percentage deviation and none deviates by more than twice that percentage (e.g. USP limits, I. P limits) o Disintegration test ▪ For most tablets, the first important step towards formation of solution is break down of the tablet into smaller particles or granules i.e. disintegration ▪ Disintegration test is performed by use of the disintegration apparatus ▪ The disintegration apparatus is comprised of glasses and a

NTA Level 6 • Semester 1 • PST06103 GMP for Pharmaceutical Premises Pharmaceutical Production • Source Session/Topic 23 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 23: GMP for Pharmaceutical Premises Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the concept of GMP on pharmaceutical premises • List the general GMP Requirements on Design of Premises • Explain how pharmaceutical manufacturing premises are maintained Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer 0 SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |20 minutes |Presentation |GMP and Manufacturing Premises | |3 |25 minutes |Presentation |General GMP Requirements on Location | | | | |of Premises | |4 | |Small group |General GMP Requirements on Design of| | |40 Minutes |discussion |Premises | | | |Presentation | | |5 |20 Minutes |Buzzing |Maintenance of Premises | | | |Presentation | | |6 |05 minutes |Presentation |Key Points | |7 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: GMP and Manufacturing Premises (20 minutes) • Good Manufacturing Practices (GMP) are a part of Quality Assurance (QA) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use • GMP is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product • GMP covers all aspects of production; o Raw materials o Premises o Equipment o Personnel • Principles of GMP are; o Proper design and construction of premises o Following written procedures and instructions o Documentation of work o Validation of work o Monitoring facilities and equipment o Writing SOPs o Designing, developing and demonstrating job competence o Protection against contamination o Controlling components and product related processes o Conducting planned and periodic audits • The premise for pharmaceutical production must meet the GMP standards STEP 3: General GMP Requirements on Location of Premises (25 minutes) • The land and buildings where the manufacturing operations are located must contribute towards the quality of the products • Proper location and design help avoid the risks of contamination, permitting effective cleaning and maintenance, minimizing the build-up of dirt and dust and preventing quality defects • Premises must be located, designed, constructed, adapted and maintained for production processes to; ➢ Minimize risks of errors and cross-contamination ➢ Permit effective cleaning ➢ Permit effective maintenance ➢ Minimize build-up of dirt and dust ➢ Eliminate any adverse effects on quality • Principle for the location of pharmaceutical production premise; o Location must minimize risks of cross-contamination ▪ Not located next to a melting factory with high airborne levels of yeast o Location must be in conducive climatic and geographic (e.g. away from noise, earthquake hazards, flooding, humidity, ) • A site inspection is useful before building commences to ensure that the area is suitable for the construction of a pharmaceutical factory STEP 4: General GMP Requirements on Design of Premises (40 minutes) |Activity: Small Group Discussion (10 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the GMP requirements on design of premise? | | | |ALLOW students to discuss for 10 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using the contents below | • Premises should be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels • Working and in-process storage space should be adequate to permit orderly and logical positioning of equipment and materials to minimize risk of confusion between different pharmaceutical products or their components, to avoid cross-contamination and to minimize the risk of omission or wrong application of any of the manufacturing or control steps • The premise must have good pipe work, light fittings and ventilation points (air handling system) • Design of the premise must include the following design features; o Design of facilities required ▪ Adequate space for future expansion ▪ Zoning laws –to allow anticipated development, restricting undesirable developments in the vicinity ▪ Availability of water (quality and quantity), power, fuel, sewage and waste removal ▪ Accessibility to employees, materials and visitors ▪ Environmental issues such as site history (soil, water, and air quality) ▪ Proximity of undesirable activities likely to cause pollution ▪ Availability of a suitable labour force ▪ Ability to provide adequate security arrangements ▪ Political situation ▪ Government stability, trade policies and taxation, financial incentives o Design of Ancillary areas ▪ Rest and refreshment rooms must be separated from manufacturing and control areas ▪ Facilities for changing and storing clothes and for washing appropriate to the number of workers ▪ Toilets should not communicate directly with production or storage areas ▪ Maintenance workshops (should be separated from production area) ▪ Animal houses should be well isolated from other areas with separate entrance (animal access) and air handling facilities o Design of Storage areas ▪ Storage areas should have sufficient capacity for orderly storage of various categories of materials and product with proper separation and segregation ▪ Storage areas should be designed or adapted to ensure good storage conditions ▪ Special storage conditions (provided, controlled, monitored and recorded appropriately) ▪ Quarantine area must be allocated to restrict access to unauthorized personnel ▪ Secure areas for storage of controlled

NTA Level 6 • Semester 1 • PST06103 GMP for Pharmaceutical Equipments Pharmaceutical Production • Source Session/Topic 24 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 24: GMP for Pharmaceutical Equipments Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the GMP requirements for equipment used in pharmaceutical manufacturing • Explain the construction features of GMP compliant equipment • Outline the basic equipment used in pharmaceutical production • Explain the calibration of equipment used in pharmaceutical production • Explain the cleaning of equipment used in pharmaceutical production • Explain the preventive maintenance of equipment used in pharmaceutical production Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Buzzing |General Features of Manufacturing | | | |Presentation |Equipment | |3 | |Small group |GMP Requirements for Equipments | | |35 minutes |discussion | | | | |Presentation | | |4 |20 Minutes |Presentation |Construction of Equipment | |5 |25 minutes |Presentation |Basic Equipment in Pharmaceutical | | | | |Manufacturing | |6 |25 Minutes |Presentation |Calibration, Cleaning and Maintenance| | | | |of Equipment | |7 |05 minutes |Presentation |Key Points | |8 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: General Features of Manufacturing Equipment (10 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the features of pharmaceutical manufacturing equipment? | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • Equipment used in the manufacture, processing, packing or holding of a drug product must be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance • Effectiveness of equipment starts at the design stage • Pharmaceutical manufacturing companies contribute indirectly in the design of equipment by providing information on requirements and feedback on existing equipment • Equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out • Equipment should be constructed of materials that suit the operation and use of the equipment for the range of products manufactured and tested on site. • The construction materials should not corrode or deteriorate and thus influence the manufacturing or testing procedure. STEP 3: GMP Requirements for Equipments (35 minutes) |Activity: Small Group Discussion (10 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | | | |What are the GMP requirements for equipment used in pharmaceutical | |production? | | | |ALLOW students to discuss for 10 minutes | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using the contents below | • Pharmaceutical manufacturing equipment should meet the following requirements; o Operating criteria ▪ Should be adequate to meet process, size, speed and effectiveness requirements o Spare parts ▪ Availability of spares and servicing ▪ This can result in using different makes of an equipment in different parts of the world o Maintenance ▪ Frequency and ease of maintenance significantly impact on productivity and even quality ▪ Equipment break down during process could adversely affect quality ▪ Cleanability of the equipment ▪ Accessibility to the parts of equipment needed to be cleaned ▪ Easy of disassembling and re-assembling the equipment o Environmental issues ▪ Dust dissemination ▪ Potential for contamination of other products and requiring operators to wear additional protective clothing and frequent cleaning of facility ▪ Noise and energy use o Equipment design, size and space required for its location o Construction materials of the equipment o Process controls on the equipment ▪ Automatic weight adjustment on tablet presses ▪ Temperature recorders on ovens o Cost of the equipment ▪ Base price of the equipment ▪ Additional costs related to installation, etc. o Design and maintenance manuals ▪ Manuals are important for validation/qualification of the equipment and maintenance programs STEP 4: Construction of Equipment (20 minutes) • Equipment layout and design must aim to minimize risks of error and permit effective cleaning and maintenance o This will avoid cross-contamination, dust and dirt-build up and any adverse effect on the quality of the product • Equipment must be installed to minimize risks of error and contamination • The construction of the equipment must meet the following features; o Surfaces ▪ Surfaces that contact components, in-process materials or drug product should be smooth, nonreactive or absorptive ▪ These surfaces should not alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements o Fixed pipework (for transfer of materials through pipelines) ▪ All pipes used must be of right standard and specification for the material and pipeline to prevent any wrong connections and mix- ups ▪ All pipes must be clearly labelled ▪ Labels in all pipes should indicate contents and direction of flow ▪ Servicing pipings and devices must be adequately marked ▪ The use of adaptors is not recommended ▪ Piping system should allow monitoring and testing of materials delivered in them at regular intervals o Substances required for operation of equipment ▪ Coolants, lubricants and other substances required for operation of the equipment

NTA Level 6 • Semester 1 • PST06103 Management of Pharmaceutical Wastes Pharmaceutical Production • Source Session/Topic 25 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 25: Management of Pharmaceutical Wastes Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Define pharmaceutical wastes • List sources of pharmaceutical wastes • List types of wastes in pharmaceutical production • Explain the problems caused by pharmaceutical wastes • Explain methods used in the disposal of pharmaceutical wastes Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Buzzing |Definitions | | | |Presentation | | |3 | |Small group |Sources of Pharmaceutical Wastes | | |35 minutes |discussion | | | | |Presentation | | |4 |30 Minutes |Presentation |Types of wastes produced during | | | | |pharmaceutical production and their | | | | |problems | |5 |30 minutes |Presentation |Disposal of Pharmaceutical wastes | |6 |05 minutes |Presentation |Key Points | |7 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Definitions (10 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What is a pharmaceutical waste? | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • Wastes are unwanted materials which are no longer used in the manufacturing process that can eventually turn into hazardous or non hazardous material to human or the environment or both • Pharmaceutical wastes are wastes are unwanted materials resulting from pharmaceutical production processes • Pharmaceutical wastes are in different forms mainly as expired materials, manufacturing wastes and others STEP 3: Sources of Pharmaceutical Wastes (35 minutes) |Activity: Small Group Discussion (15 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the sources of waste in pharmaceutical manufacturing? | | | |ALLOW students to discuss for 15 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using the contents below | • Manufacturing processes o Wastes generated during pharmaceutical production ▪ by-products from different stages of manufacturing ▪ Spillages ▪ Waste water • Raw materials o Unusable/expired/rejected/obsolete raw materials o Expired/unusable/rejected active pharmaceutical ingredients • Products o Rejected finished products • Packaging materials o Unusable or damaged packaging materials • Quality control laboratories o Used chemical by products o Spills o Unused/unusable solvents, chemicals and reagents o Waste water • Cleaning and maintenance processes o Cleaning substances e.g. detergents, soaps o Waste waster STEP 4: Types of Wastes Produced in Pharmaceutical Production and their Problems (30 minutes) • Pharmaceutical wastes are classified into o Hazardous wastes o Non-hazardous wastes o Hazardous wastes ▪ Hazardous wastes are wastes that are dangerous or potentially harmful to human health or environment ▪ Hazardous wastes can be liquids, solids, gases or sludges ▪ Hazardous wastes exhibit hazardous properties such as: Ignitability ▪ Ignitibility is a property of a pharmaceutical waste to present fire hazard under routine storage, disposal and transportation or are capable of exacerbating a fire once it has started ▪ Ignitable wastes are easily combustible or flammable ▪ Ignitable wastes include flammable liquids and compressed gases Corrositity ▪ Corrosive pharmaceutical wastes are wastes capable or corroding metals or other materials or burn the skin ▪ These have a pH of 2 or lower or 12.5 or higher Reactivity ▪ Reactive wastes are unstable under normal conditions ▪ They undergo violent changes ▪ They can cause explosions, toxic fumes, gases or vapours when heated, compressed, or mixed with water ▪ They include glacial acetic acid, sodium hydroxide etc Toxicity ▪ Wastes that are toxic contain toxic organic chemicals or toxic heavy metals such as chromium, lead, mercury or cadmium Infectivity ▪ Ability of waste to cause infection ▪ These are from microbiological laboratories or from production of vaccines or immunological preparations o Non-hazardous wastes ▪ Non-hazardous pharmaceutical wastes are those wastes that present no significant hazardous properties ▪ These wastes are below the threshold of causing harm to human health • Problems associated with pharmaceutical wastes |Activity: Small Group Discussion (15 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the problems associated with industrial pharmaceutical | |wastes? | | | |ALLOW students to discuss for 15 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned| | | | | |CLARIFY and SUMMARIZE by using the contents below | o Environmental contamination with drug substances ▪ Fumes, dust etc. ▪ Antimicrobial resistance when antimicrobial wastes contaminate the environment STEP 5: Disposal of Pharmaceutical Wastes (30 minutes) • Methods for disposal of pharmaceutical wastes; o Incineration ▪ Incineration is an effective method for disposal of wastes (solid, liquid and gaseous waste), in which solid organic wastes are subjected to combustion so as to convert them into residue and gaseous products (heat, gas, steam and ash) by use of an incinerator ▪ Is useful for disposal of residue of both solid waste management and solid residue from waste water management ▪ Reduces the volumes of