Validation Protocol Template for Hot Detergent and Hot PUW Generation and Distribution System

This C&Q assignment consists of populating various sections of a Validation Protocol template for the Hot Detergent and Hot PUW Generation and Distribution System that you have been studying. Always remember that you must fully understand the process system before you can confidently populate your verification protocol, i.e. understanding what is critical about it and what its critical design features are. Be aware that the questions/instructions for completing the protocol do not follow the sequence of headings in the table of contents for the protocol (as is the norm in a field validation exercise) and you can presume that Actual Results meets the Expected Results for each test and the equipment system will PASS (not FAIL). We have attached some detailed instructions to help clarify the level of detail that is expected in your completed protocol – and contact us if you need further clarification. There is quite a lot of work/hours needed for this assignment so we recommend that you get started on this as soon as possible so the next number of weeks you will need to manage your time between normal studies of the Weekly Sessions and working on this assignment. There are three files to download: 1. Detailed Instructions for C&Q Assignment (as per attached) 2. Assignment Descriptor (to follow on subsequent Announcement) 3. Verification Protocol Template (to follow on subsequent Announcement)

Protocol Objective

The objective of this protocol is to provide testing evidence that will prove that the ‘Hot Detergent and Hot PUW Generation and Distribution’ system is fit for its intended use. Testing will incorporate both installation verification and functional verification test.

System Description

Prepare a summary ‘System Description’. Suggestions include drawing a process flow / block diagram; listing critical operational features; and, describing the major equipment components in the context of their installation and functional features.

The system consists of a series of tanks and piping as well as heat exchanges that are used to generate and transport hot water (steam) for the purposes of sterilization of medical production systems to ensure the produced medicines are i8mpurity free and safe from any contaminants. The system consists of a boiler that generates heat for boiling water to a safe temperature. The pure steam is then transported through a series of pipes and piping’s that are then used for tank sterilization. The pure hot steam is also used in sterilizing piping systems, filters, and products that are contained within sterilizers. Some tanks within the system are used as sterilizers for pharmaceutical products. The system also moistens air in clean room systems while the detergents are used for further after cleaning. Among the most crucial pipeline in the system is 50-PUW1-S6-148-IH which carries out hot vapour, if this pipeline is not been handled for example if the valve opening fails in this pipeline will ultimately results in high pressure build-up leads to explosive incident