PRODUCTION QUESTIONS 2004 Exams 3. Your company is a toiletries manufacturing company that has expanded over the last five years and has now been approached to manufacture a new range of colour cosmetics. A project team is to be set up to review and make recommendations on the equipment required, factory layout and how the products should be Quality Controlled at both the bulk and filling stages. You are to be the technical services representative (R&D and QC) on this project. Outline the different types of bulk manufacturing and filling equipment required and what type of grouping/layout should be used. When answering this question I would be looking for a discussion on the types of equipment used and their layout in the factory to manufacture of powder, emulsion and stick colour cosmetics. 4. Answer both parts:a) Write a short essay on the various process steps and equipment necessary for the large-scale manufacture of a water in oil emulsion. Include a brief outline formulation and discuss the importance of Good Manufacturing Practice in the production environment and raw material usage traceability . When answering this question I would be looking for the different steps in the manufacture of an emulsion from weighing out the raw materials (outline formulation), cleaning the vessel, GMP. b) You are responsible for the manufacture of a new oil in water formulation. The first three batches have not met specification. There has been one batch with a microbiological failure, one batch with low viscosity and one batch with both low viscosity and microbiological failure. Outline the steps you would take to investigate the possible causes. To answer this question you will need practical experience either in the lab or from a Production site on route cause analysis. What raw materials in your formulation would affect the product viscosity and what would affect the microbiological condition of the production batch. 2005 Exams 3. Answer both parts:a) Describe the main techniques used to manufacture and fill a lipstick. b) Describe the main techniques used to manufacture and fill liquid foundations. Please give outline formulations for your answers and describe how you would adjust the colour if it needed correction. In this two part question I would be looking for a discussion on the different types of equipment used in the factory to manufacture and fill: a. lipsticks both automatic and manual – melting and mixing vessel b. liquid foundation emulsions – cream processing vessel Details of how you would apply colour correct each type should also be included. 4. Answer both parts:a) What design features need to be considered when planning a new toiletry production unit? I would be looking for a discussion on why equipment should be grouped together according to product type, raw materials used, filling speed and production volumes. b) Identify the major departments of such an operation and briefly describe their primary responsibilities and how they interact with each other. I would be looking for a description and responsibilities of each department and how they interact with each other in your organisation or from the module as there are no right or wrong answers as there are so many different organisational structures depending upon the size of the company. 2006 Exams 3. Answer both parts:a. Write a short essay describing the manufacturing process and equipment used in large scale manufacture of a shower gel. Include an outline formulation based on using 70% SLES, (Sodium Lauryl Ether Sulphate), the importance of Good Manufacturing Practice and raw material usage traceability. Also discuss what quality testing is required to be carried out on the bulk product. I would be looking for discussion of a typical formulation and equipment used to manufacture a shower gel, storage and traceability of raw materials, bulk and the importance of Good Manufacturing Practice – plant hygiene. How the SLES and other raw materials are added to the water as well as how the final bulk product is tested – pH, viscosity, and microbiological. b. You are responsible for the manufacture of a new carbomer based hair gel formulation with 5% ethanol. The first two batches have failed the microbiological test and have low viscosities, therefore they have not met the specification. Outline the steps you would take to investigate the possible causes. Include a discussion on the importance of water quality in this type of formulation. I would be looking for a discussion on a carbomer based hair gel formulation, the manufacturing method used and the manufacturing equipment used – high shear mixing vessel with side phase units. What can influence the effectiveness of the preservative system and viscosity. Here we are looking for a Route Cause Analysis covering each stage. 4. Answer both parts:a. When preparing production plans for (a) one week and (b) one month what is the key information required. Comment on the importance of this information I would looking for a breakdown of the key issues that would effect a production run – component and bulk availability, equipment, staff, bulk and new raw materials, launch dates for NPD. b. Write brief notes on key departments involved in in the new product launch process. Briefly describe their primary responsibilities and why they are important. I would be looking for a description and responsibilities of each department marketing, R&D, operations, technical group, finance, customer service, - to name few and how they interact with each other in your organisation or from the module as there are no right or wrong answers as there are so many different organisational structures depending upon the size of the company 2007 Exams 2. Discuss the advantages and disadvantages of grouping the different types of bulk manufacturing and filling equipment together along product lines when designing a factory layout. Include in the discussion a description of the different types of manufacturing and filling equipment used for each product type; the importance of Good Manufacturing Practice in the layout of a manufacturing and filling area and the importance of clean water. I would be looking for a discussion on why manufacturing and filling equipment should be grouped together according to product type: detergent based products, creams coloured and uncoloured, coloured powders, raw materials used, filling speed and production volumes when laying out a factory. Also include a discussion on the quality of water which is a major raw material used in many products and the importance of GMP – good clearing procedures, how raw materials should be dispensed – labelled and sealed. 2008 Exams 2. Answer any TWO of the following:a. Write a short essay on the importance of good process vessel design. Include the factors that will influence the different types of flow patterns generated in a process vessel and how the flow patterns can be improved. The use of diagrams will help to demonstrate your understanding. Here I would be looking for a discussion on the design of a mixing vessel including: Shape of the vessel, design of the impellers, the position of the impeller and baffles, tangential flow, Radial flow, Axial flow. Flow patterns generated by differing positions of the impeller and baffles. The rotor/stator mixer functions by reducing the particle size the bulk passes through the very small gap between the two surfaces I would be looking for a discussion on good process vessel design – so b. Discuss the manufacturing procedures and equipment used in the manufacture of a powder cosmetic of your choice. Include how you would adjust the colour if it required correction Here I would be looking for a discussion on the different types of equipment used to manufacture powder cosmetic – the types of mills used to grind the pigments, the types of mixer – trough etc. Colour adjustment is made by mixing neat colour with a small amount of the batch, passing the resulting mix through mill to fully extent the colours before adding it to the main batch and mixing until uniform. 2009 Exams 2. Answer both parts:a) Describe the various types of flow that can be generated in a mixing vessel used for the manufacture of a low to medium viscosity liquid. Also describe why you would use a rotor/stator homogeniser. Illustrate your answer with appropriate labelled diagrams. Here I would be looking for a discussion on the design of a mixing vessel including: Shape of the vessel, design of the impellers, the position of the impeller and baffles, tangential flow, Radial flow, Axial flow. Flow patterns generated by differing positions of the impeller and baffles. The rotor/stator mixer functions by reducing the particle size the bulk passes through the very small gap between the two surfaces. b) You are responsible for the manufacture of a new carbomer based hair gel formulation with 5% ethanol. Include an outline formulation indicating the function of each raw material. The first two batches have not met the specification and there has been:i) One microbiological failure ii) One low viscosity Outline the steps you would take to investigate the possible causes. Include in your answer the importance of water quality in this type of formulation. I would be looking for a discussion on a carbomer based hair gel formulation, the manufacturing method used and what can influence the effectiveness of the preservative system and viscosity. Here we are looking for a Route Cause Analysis covering each stage. 8. Answer both parts:a) Write an essay describing the manufacturing process and the equipment used in the large scale manufacture of a shower gel. Include in your answer an outline formulation that uses 70% active sodium laureth sulphate. Describe the function of each raw material, the importance of Good Manufacturing Practice and raw material usage traceability. Also describe what quality testing is required for the bulk product. I would be looking for discussion of a typical formulation and equipment used to manufacture a shower gel, storage and traceability of raw materials, bulk and the importance of Good Manufacturing Practice – plant hygiene. How the SLES and other raw materials are added to the water as well as how the final bulk product is tested – pH, viscosity, and microbiological. b) Write an essay on your understanding of the term Good Manufacturing Practice, as used in the cosmetics and toiletries industry. Give clear examples to demonstrate your understanding. Here I would be looking for a detailed discussion on your understanding of GMP covering – the testing, control and traceability of raw materials, bulk, components, and procedures used for cleaning manufacturing and filling equipment.