Pharmaceutical Sciences Notes

NTA Level 5 • Semester 2 • PST05207 GMP Equipments Requirements Quality Assurance of Pharmaceutical Products • Source Session/Topic 6 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 6: GMP Equipments Requirements 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 Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 10 minutes Buzzing 2 General Features of Manufacturing Equipment Presentation Small group 3 35 minutes discussion GMP Requirements for Equipments Presentation 4 20 Minutes Presentation Construction of Equipment 20 minutes Basic Equipment in Pharmaceutical 5 Presentation Manufacturing 20 Minutes Calibration, Cleaning and Maintenance of 6 Presentation Equipment 7 05 minutes Presentation Key Points 8 05 minutes Presentation Evaluation 38 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 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 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 39 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2  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) 40 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2  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 should not come into contact with components, drug product, containers, closures, in-process materials or drug product  Lubrication needs to be of good grade, controlled and monitored o Potential sources of contamination  Construction of equipment should be in a such a way that motors, drive belts, gears and other potential sources of lubricant contamination are located away from vessels or package openings that could result in product contamination

NTA Level 5 • Semester 2 • PST05207 Quality Control and Assurance in Relation to Preparation of Pharmaceutical Products Quality Assurance of Pharmaceutical Products • Source Session/Topic 7 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 7: Quality Control and Assurance in Relation to Preparation of Pharmaceutical Products Total Session Time: 120 minutes Prerequisites Learning Tasks By the end of this session students are expected to be able to: • Define quality • Outline the importance of quality in relation to preparation of pharmaceutical products • Define quality assurance • Define quality Control • QC/QA comparisons • List functions of quality control laboratory in relation to preparation of pharmaceutical products Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Presentation 2 Definition of Quality Buzzing 10 Minutes Presentation 3 Importance of Quality 4 10 minutes Presentation Definition of Quality Control 15 minutes Presentation 5 Definition of Quality Assurance 20 minutes Presentation 6 QC/QA Comparisons Brain storming Functions of Quality Control Laboratory in Presentation Relation to Preparation of Pharmaceutical 7 35 minutes Products 8 05 minutes Presentation Key Points 9 05 minutes Presentation Evaluation 45 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 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: Definition of Quality (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What is quality? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below The equipments used in facility based pharmaceutical preparation unit include the following • Quality is a set of inherent properties of a product, system or process fulfills requirements. (Customer satisfaction). The ability of a product or service to satisfy the specific customer needs. Achieved by conforming to established requirements and standards. Or alternatively quality can be defined as; Is the attribute or collection of attributes appropriate for intended use. Is the attribute or collection of attributes desirable for intended use? Quality = E2+C, EFFECTIVENESS – Meeting Customer Needs EFFICIENCY – Quantity of Resources used to meet needs COMPLIANCE – Meeting Regulatory Requirements. The typical dictionary definition of quality refers to the „„degree or grade of excellence‟‟; in this sense, quality is a relative measure of goodness. Defining quality as goodness is so General that it offers no operational content. How do we build an operational definition? The answer is, „„Adopt a customer focus.‟‟ Operationally, a quality product or service is one that meets or exceeds customer expectations? In effect, quality is customer satisfaction. ut what is meant by „„customer expectations‟‟? Customer expectations can be Described by quality attributes or by what are often referred to as „„dimensions of quality. ‟Thus, a quality product or service is one that meets or exceeds customer expectations on the following eight dimensions: 1. Performance 2. Aesthetics 3. Serviceability 46 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 4. Features 5. Reliability 6. Durability 7. Quality of conformance 8. Fitness for use The first four dimensions describe important quality attributes but are difficult to measure. Performance: refers to how consistently and how well a product functions. For services, the inseparability principle means that the service is performed in the presence of the customer. Thus, the performance dimension for services can be further defined by the attributes of responsiveness, assurance, and empathy. Responsiveness is simply the willingness to help customers and provide prompt, consistent service. Assurance refers to the knowledge and courtesy of employees and their ability to convey trust and confidence. Empathy means providing caring, individualized attention to customers. Aesthetics: is concerned with the appearance of tangible products (for example, style and beauty) as well as the appearance of the facilities, equipment, personnel, and communication materials associated with services. Serviceability: measures the ease of maintaining and/or repairing the product. Features (quality of design) refer to characteristics of a product that differentiate between functionally similar products. For example, the function of automobiles is to provide transportation. Yet, one auto may have a four-cylinder engine, a manual transmission, vinyl seats, room to seat four passengers comfortably, and front disk brakes; another may have a six-cylinder engine, an automatic transmission, leather seats, room to seat six passengers comfortably, and antilock brakes. Similarly, first class air travel and economy air travel reflect different design qualities. First-class air travel, for example, offers more leg room and more luxurious seats. Obviously, in both cases, the product features are different. Higher design quality is usually reflected in higher manufacturing costs and in higher selling prices. Quality of design helps a company determine its market. A market exists for the four-cylinder and the six-cylinder cars as well as economy air travel and first-class air travel. Reliability: is the probability that the product or service will perform its intended function for a specified length of time. Durability: is defined as the length of time a product functions. Quality of conformance: is a measure of how a product meets its specifications. For example, the specifications for a machined part may be a drilled hole that is three inches in diameter, plus or minus /8 inch. Parts falling within this range are defined as conforming parts. Fitness of use: is the suitability of the product for carrying out its advertised functions. If 47 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 there is a fundamental design flaw, the product may fail in the field even if it conforms to its specifications. Product recalls

NTA Level 5 • Semester 2 • PST05207 The Operating Principles of Equipments and Machines Quality Assurance of Pharmaceutical Products • Source Session/Topic 8 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 8: The Operating Principles of Equipments and Machines Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List equipment used in facility based pharmaceutical preparation unit (Reverse Osmosis Machine, Distiller, Autoclave, De-ionizer etc.) • Explain the operating principles of an Autoclave • Explain the operating principles of a Reverse Osmosis Machine • Explain the operating principles of a De-ionizer • Explain the operating principles of a Distiller Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD Projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 10 minutes Presentation Equipment Used in Facility Based 2 Buzzing Pharmaceutical Preparation Unit 25 Minutes Presentation Operating Principles of an Autoclave 3 30minutes Operating Principles of a Reverse Osmosis 4 Presentation Machine 20 minutes Presentation 5 Operating Principles of a De-ionizer 20 minutes Presentation 6 Operating Principles of a Distiller 7 05 minutes Presentation Key points 8 05 minutes Presentation Evaluation 56 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Equipment Used in Facility Based Pharmaceutical Preparation Unit(10 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What are equipments used in facility based pharmaceutical preparation unit? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below The equipment used in facility based pharmaceutical preparation unit include the following: • Reverse Osmosis Machine, • Distiller, • Autoclave, • De-ionizer STEP 3: Operating Principles of an Autoclave (25 minutes) • The autoclave involves sterilization of materials using steam and pressure is a dependable procedure for the destruction of all forms of microbial life. • However, the autoclave must be properly used and understood to be effective. • Do not assume that merely pushing the button on an autoclave will result in the proper sterilization of your materials. • There are some established guidelines for the effective use of steam sterilizers (autoclaves) for the decontamination of cultures and other materials, for preparing sterile supplies, and for the safe operation of the autoclave. 57 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 Figure 8:1 Autoclave machine Source: KSP IV Production Mannual • The theory of operation o The basics: Why is an autoclave such an effective sterilizer? An autoclave is a large pressure cooker; it operates by using steam under pressure as the sterilizing agent.  High pressures enable steam to reach high temperatures, thus increasing its heat content and killing power.  Most of the heating power of steam comes from its latent heat of vaporization. This is the amount of heat required to convert boiling water to steam.  This amount of heat is large compared to that required to make water hot. For example, it takes 80 calories to make 1 liter of water boil, but 540 calories to convert that boiling water to steam.  Therefore, steam at 100º C has almost seven times more heat than boiling water. Steam is able to penetrate objects with cooler temperatures. o How does killing occur? Moist heat is thought to kill microorganisms by causing coagulation of essential proteins.  Another way to explain this is that when heat is used as a sterilizing agent, the vibratory motion of every molecule of a microorganism is increased to levels that induce the cleavage of intra-molecular hydrogen bonds between proteins.  Death is therefore caused by an accumulation of irreversible damage to all metabolic functions of the organism.  Death rate is directly proportional to the concentration of microorganisms at any given time. The time required to kill a known population of microorganisms in a specific suspension at a particular temperature is referred to as thermal death time (TDT). 58 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2  All autoclaves operate on a time/temperature relationship; increasing the temperature decreases TDT, and lowering the temperature increases TDT. o What is the standard temperature and pressure of an autoclave? Processes conducted at high temperatures for short time periods are preferred over lower temperatures for longer times. Some standard temperatures/pressures employed are 115 °C/10 p.s.i., 121°C/ 15 p.s.i., and 132 °C/27 p.s.i. (psi=pounds per square inch).  Please note that after loading and starting the autoclave, the processing time is measured after the autoclave reaches normal operating conditions of 121°C (250°F) and 15 psi pressure, NOT simply from the time you push on the bottom. o Time is critical. As the cycle time will vary with the composition of the load, it is important to determine the appropriate time requirement. Some (ignorant) people assuming that a time of 30 minutes is sufficient, however this often proves to be a very costly mistake. o Volume. Obviously, the higher the volume, the more time is needed for sterilization (see general guidelines below). Generally, the volume of liquid per container is a more important consideration than the total volume. A 2-liter flask containing 1-liter of liquid takes longer to sterilize than four 500 mL flasks each containing 250-mL of liquid. o Microbial load. Contaminated items take longer to sterilize than clean items. Consequently, water sterilizes faster than yeast-extract containing media (which contains lots of microbes), or media left at room temperature for a

NTA Level 5 • Semester 2 • PST05207 Standard Operating Procedures for Equipments and Machines Quality Assurance of Pharmaceutical Products • Source Session/Topic 9 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 9: Standard Operating Procedures for Equipments and Machines Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define standard operating procedures • Explain the components of an SOP • Explain the importance of SOPs in the production of pharmaceuticals Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Definition of Standard Operating Presentation 2 Procedures Buzzing 30 minutes Presentation Components of an SOP 3 Brainstorming, 60 minutes Presentation Importance of SOPs in the Production of Pharmaceuticals 4 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation 67 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 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: Definition of Standard Operating Procedures (15minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is Standard Operating Procedures? 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 • Standard Operating Procedures (SOPs) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre- determined specification and quality end-result. • SOPs must contain step by step instructions that employ must refer in daily work to complete various tasks more reliably and consistently. • SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. STEP 3: Components of an SOP (30minutes) Activity: Brainstorming (5minutes) ASK student to brainstorm on the following question • What are the components of SOP? ALLOW few students to respond WRITE their responses to the flip chart/ board CLARIFY and SUMMARIZE by using the content below The following are components of standard operating procedures (SOP) 68 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 • Scope-the activity which is to be covered by the SOP • Objective-the purpose of following the procedure • Responsibility-who will be carrying out the activity • Procedure-instructions on what to be done • Audit-to identify areas of improvement STEP 4: Importance of SOPs in the Production of Pharmaceuticals (60minutes) The following are importance of SOPs in the production of pharmaceuticals: • It provides people with all the safety, health, environmental and operational information necessary to perform a job properly. Placing value only on production while ignoring safety, health and environment is costly in the long run. It is better to train employees in all aspects of doing a job than to face accidents, fines and litigation later. • It ensures that production operations are performed consistently to maintain quality control of processes and products. Consumers, from individuals to companies, want products of consistent quality and specifications. SOPs specify job steps that help standardize products and therefore quality. • It ensures that processes continue uninterrupted and are completed on a prescribed schedule. By following SOPs, you help ensure against process shut-downs caused by equipment failure or other facility damage. • It ensures that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage. • It serves as a training document for teaching users about the process for which the SOP was written. Thorough SOPs can be used as the basis for providing standardized training for employees who are new to a particular job and for those who need re-training • It serves as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of proper job performance. When the proper procedures are outlined in a good SOP, any co-worker can coach another to help improve work skills • It serves as a checklist for auditors. Auditing job performance is a process similar to observation mentioned in the previous item only it usually involves record keeping. SOPs should serve as a strong basis when detailed audit checklists are developed. STEP 5: Key Points ( 5 minutes) • SOPs are a set of written instructions that document a routine or repetitive activity which is to be followed. • Components of SOP include scope, objectives, responsibility, procedures and audit. 69 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 • SOPs serves as checklist for co-workers and auditors, training document, ensures no failures occur during production and provides safety among people. STEP 6: Evaluation (5 minutes) • What is SOPs? • What are the components of SOPs? • What is the importance of SOP? 70 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 References Saluja, Gp. “Chapter-01 Standard Operating Procedure for Preparing, Revising and Using Standard Operating Procedures SOPs .” Standard Operating Procedures and Regulatory Guidelines: Blood Banking, 2014. Saluja, G. (2014). Chapter-01 Standard Operating Procedure for Preparing, Revising and Using Standard Operating Procedures (SOPs). Standard Operating Procedures and Regulatory Guidelines: Blood Banking. Moriarty, D. (2015). Error management and standard

NTA Level 5 • Semester 2 • PST05207 Preventive Maintenance Procedures for Equipments and Machines Quality Assurance of Pharmaceutical Products • Source Session/Topic 10 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 10: Preventive Maintenance Procedures for Equipments and Machines Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the importance of proper preventive maintenance of equipment and machines • Describe general considerations in preventive maintenance of machines and equipment • Describe preventive maintenance procedures for equipment and machines (Reverse Osmosis Machine, Distiller, Autoclave, De-ionizer etc.) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 45 minutes Presentation Importance of Proper Preventive 2 Buzzing Maintenance of Equipment and Machines 10 minutes General Considerations in Preventive 3 presentation Maintenance of Machines and Equipment 50 minutes Presentation Preventive Maintenance Procedures for 4 Brainstorming Equipment and Machines 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation 72 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Importance of Proper Preventive Maintenance of Equipment and Machines (45minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What is preventive maintenance? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • The goal of maintenance is to keep the production system in good working order at minimal cost • Maintenance –include all activities that maintain facilities and equipment in good working order so that a system can perform as intended • Goals of Maintenance-To keep production systems in good working order at minimal cost • Reasons for maintenance o To avoid production or service disruptions o To not add production or service costs o To maintain high quality o To avoid missed delivery dates • Preventive maintenance: goal is to reduce the incidence of breakdowns or failures in the plant or equipment to avoid the associated costs • Preventative Maintenance is a way to catch small issues with your machine before they become big issues OR involves maintenance performed to extend the life of the device and prevent failure • Preventive maintenance is “that function of manufacturing management that is concerned with day to day problem of keeping the physical plant in good operating condition” • Preventive maintenance is periodic o Result of planned inspections o According to calendar o After predetermined number of hours • Five Components of a maintenance 73 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Breakdown maintenance or corrective maintenance; Occurs when there is a work stoppage due to machine breakdown o Preventive maintenance; It is undertaken before the need arises and aims to minimize the possibility of un -anticipated production interruption or major breakdowns o Predictive maintenance; Conditions can be measured on a continuous basis and this enables the maintenance people to plan for an overhaul. o Routine maintenance; this includes activities such as periodic inspection, cleaning, lubrication and repair of production equipments after their service life o Planned maintenance; : it involves the inspection of all plant and equipments, machinery, buildings according to a predetermined schedule in order to service overhaul, lubricate or repair, before actual break down or deterioration in service occurs • Principle Objectives in Maintenance o To achieve product quality and customer satisfaction through adjusted and serviced equipment o Maximize useful life of equipment o Keep equipment safe and prevent safety hazards o Minimize frequency and severity of interruptions o Maximize production capacity – through high utilization of facility • Advantages o Reduces break down and thereby down time o Lass odd-time repair and reduces over time of crews o Greater safety of workers o Lower maintenance and repair costs o Less stand-by equipments and spare parts o Better product quality and fewer reworks and scraps o Increases plant life o Increases chances to get production incentive bonus • Importance of proper preventive maintenance of equipment and machines o Dependability of service o Assured quality o Prevent equipment failure o Cost control o Huge investment in equipment STEP 3: Considerations in Preventive Maintenance of Machines and Equipment (10 minutes) • Preventive Maintenance general considerations consists of o Proper design and installation of equipment o Documentation on Predictive Maintenance o Periodic inspection of plant and other equipments if properly functioning o Repetitive servicing and overhaul of malfunctioning equipment 74 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Adequate lubrication, cleaning and painting o Using of Personal Protective Equipments (PPE) o Preventive maintenance Benefits and Control STEP 4: Preventive Maintenance Procedures for Equipment and Machines (Reverse Osmosis Machine, Distiller, Autoclave, (50 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What are PM procedures for RO machine? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Preventive maintenance procedures for reverse osmosis machine o Design, Construction and Preventive maintenance of USP Purified Water Systems o Reverse Osmosis (RO) is a well-established process o For an RO system to work reliably and economically, the unit and associated equipment must be routinely maintained o Reverse osmosis is the most economical method of removing up to 99% of feed water contaminants o Requires pretreatment to avoid damaging the membrane; o A Typical reverse osmosis preventive maintenance Checklist must be present in

NTA Level 5 • Semester 2 • PST05207 Procedures for Quality Testing of Pharmaceutical Products Quality Assurance of Pharmaceutical Products • Source Session/Topic 11 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 11: Procedures for Quality Testing of Pharmaceutical Products Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List methods commonly used for quality testing of pharmaceutical products from monographs • Explain procedures for carrying out physical quality tests for solid pharmaceutical dosage forms (Hardness, smell, colour, texture, thickness, diameter, friability, disintegration etc.) • Explain procedures for carrying out physical quality tests for liquid pharmaceutical dosage forms (pH, smell, colour, conductivity, osmolarity etc.) • Explain procedures for carrying out microbiological quality tests for pharmaceutical products (sterility tests, etc.) • Explain procedures for carrying out chemical qualitative tests (volumetric analysis, colour reaction, dissolution test etc.) • Explain procedures for carrying out chromatographic quality tests (TLC, etc.) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer 79 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 15 minutes Methods Commonly Used for Quality Presentation 2 Testing of Pharmaceutical Products from Buzzing Monographs 20 minutes Procedures for Carrying Out Physical Presentation and 3 Quality Tests for Solid Pharmaceutical Brainstorming Dosage Forms Procedures for Carrying Out Physical 4 20 minutes Presentation Quality Tests for Liquid Pharmaceutical Dosage Forms 15 minutes Procedures for Carrying Out 5 Presentation Microbiological Quality Tests for Pharmaceutical Products 15 minutes Presentation Procedures for Carrying Out Chemical 6 Qualitative Tests 20 minutes Presentation Procedures for Carrying Out 7 Chromatographic Quality Tests 8 05 minutes Presentation Key Points 9 05 minutes Presentation Evaluation 80 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Methods Commonly Used for Quality Testing of Pharmaceutical Products from Monographs (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 2 minutes • What are various tests in quality testing of pharmaceutical products? ALLOW few pairs to respond and let other pairs add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • There are various tests involve in quality testing of pharmaceutical products, these includes • Physical quality tests for solid pharmaceutical dosage forms includes; o Hardness, o Smell, o Colour, o Texture, o Thickness, o Diameter, o Friability test, o Disintegration test • Chromatographic quality tests includes o Thin layer chromatography method-TLC o High-performance liquid chromatography (HPLC o Gas chromatography (GC) o Paper chromatography • Physical quality tests for liquid pharmaceutical dosage forms includes o pH, o Smell, o Colour, o Conductivity, o Osmolarity • Microbiological quality test include 81 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Sterility tests for pharmaceutical products o Chemical qualitative tests includes Volumetric analysis o Colour reaction, Dissolution test STEP 3: Procedures for Carrying out Physical Quality Tests for Solid Pharmaceutical Dosage Forms (20 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What is disintegration? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Disintegration is the process where pharmaceutical solid dosage forms separate into parts or lose intactness or solidness and break up into particle or constituent under specified conditions • Disintegration time is the time required for a dosage form to break up in to granules of specified size (or smaller) under carefully specified conditions. • Disintegration Test- This test determines whether dosage forms such as tablets, capsules, pessaries and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. For the purpose of this test, disintegration does not imply complete solution of the dosage unit or even of its active constituent. • Disintegration Apparatus consists of o A basket-rack assembly, o A 1-litre beaker, o A thermostatic arrangement for heating the fluid o Mechanical device for raising and lowering the basket in the immersion fluid at a constant frequency rate • Disintegration test procedures o 6 tablets from each batch are taken and subjected to the disintegration test. o One tablet is placed in the mesh screen at the bottom end of each of the 6 glass tubes, o Tap water is used as disintegration medium. Simulated gastric fluid. o The apparatus is maintained at a temperature of 37 ± 2°C. o Glass tube maintains up and down movement in and out of the basket containing 1000mls distilled water. the basket move through a distance of 5-6cm at a frequency of 28 to 32 cycles per minutes as specified by U.S.P 82 PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2 o Disintegration time of the each tablet is noted by means of a stopwatch and recorded. o Disintegration time does differ depending on the nature of the tablets e.g. uncoated, coated. Uncoated USP tablets have disintegration time as low as 5 minutes but majority have maximum disintegration time of 30 minutes. Disintegration test we start with 6 tablets if one or two tablets failed to disintegrate completely test should be repeated for additional 12 tablets the requirement met if not less than 16 of the total 18 are disintegrated. • Factors affecting the disintegration time o Content-especially the quality and quantity of the Disintergrants and lubricant. o Hardness .amount of binder, compression force. o Design of granulation procedure which will affect