Pharmatopia Sterile Clean Room User Guide moodle PDF

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Download Pharmatopia Sterile Clean Room User Guide moodle PDF

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Virtual Sterile Clean Room – User Guide Introduction Principles and practices of contamination control and sterile processing are taught in B.Pharm drug delivery curriculum. Learning objectives of this topic area include: to appreciate specialised work environment required for preparation of sterile pharmaceuticals; to be familiar with contamination control features and mechanisms used to create and maintain GMP standard cleanrooms, environmental monitoring procedures to check if these cleanrooms meet recommended standards, personnel cleanroom procedures such as gowning and hand-washing procedures, set-up and aseptic processing in the laminar flow cabinets. To enhance your learning engagement and enable you to explore these principles and practices in an interactive environment, a virtual learning facility called “Sterile Clean Rooms” has been developed giving you flexible and independent learning opportunities.

Getting Started The Virtual Sterile Clean Rooms (we will abbreviate this to the ‘SCR’ from now on) is a 3D interactive simulation of a hospital pharmacy sterile production facility. The SCR runs in a software system called Unity 3D. To use the simulation at home you will need to install the Unity player on your PC. If you want to download the Unity player for you browser at home the link is: http://unity3d.com/webplayer/

Accessing SCR You will be provided with access to the SCR via Moodle.

After the simulation has loaded, which may take a few seconds, the first screen you will see asks you to choose a gender for your character.

After that you will see the instructions screen, read the instructions then click on the ‘close’ button to begin the simulation.

Moving around the SCR Use the cursor keys or WASD keys to move around. Use the mouse to find objects that you can interact with and to click on. Interactive objects will highlight in red when you move your mouse over them. However, you will need to be close enough to an object to click on it, so don’t try to click on a door from the other side of the room and expect it to work. Copyright © Monash University 2014

Gowning Up As you enter the SCR stop walking just after you get through the door - you will be standing on a sticky mat. You will see a shelf to your right - this contains cleanroom clothing items you will need to put on before going any further into the SCR. Click on the shelves to enter the gowning screen.

The gowning screen To take clothing off, drag the item from the body to the shelf (this is restricted to shoes). To put items on, drag the item from the shelf to the appropriate body region shown in the screen shot below. Remember that the sequence of gowning is important.

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Head Right hand

Left hand

Torso

Right Foot

Left Foot

Checking the Environment When working in a sterile production facility it is important to ensure that the cleanroom environment is running optimally. You will need to check that the air pressure differentials, particulate and microbial levels of the cleanrooms are within acceptable limits. There are three items in this facility that allow you to check the environment: •

• •

The incubator - contains agar plates that have been exposed to cleanroom air in key areas of the facility. You should check these air sampling results to ensure that microbial limits are met in these cleanrooms. The Particle counter – gives a reading of the number of particles in the sampled cleanroom air. Check to ensure that these are within acceptable limits. The Pressure Gauges – show measured air pressures in each of the cleanrooms in the facility. Check them to make sure that all rooms conform to guidelines.

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Pressure Gauges

Incubator

Particle Counter

Click on each of the environment monitors in turn. You will be able to check the status of each item and decide whether the readings are acceptable or outside of operating parameters. If you think the cleanroom operating environment is not meeting acceptable standards, you should call the maintenance department; if you do this you will see another screen that allows you to describe the problem to so that it can be quickly fixed. If you call maintenance you will be prompted again to check the operating parameters and decide whether they are acceptable.

Click on the “?” button to see the standard operating reference for that item.

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Receiving the Prescription

Once you have checked the operating environment you will be able to receive the prescription for your exercise. Walk over to the prescription hatch and a doctor will hand you the prescription.

The prescription will contain all of the information you need to prepare the sterile product for dispensing. Click on the cross button on the prescription to remove it from the display. You can see it at any time by clicking on the icon in the menu bar.

Working at the Computer You will now need to complete some computer dispensing work in the ‘admin room’ before you can make up the prescribed sterile preparation in the cleanrooms. Click on the computer screen to access the SCR computer system. There are three activities to complete using the computer: 1. Creating a dispensing label. 2. Performing the necessary dilution calculations. 3. Compiling a pick list of the items you will need to prepare the product.

Click on the tabs at the right hand side of the computer screen to perform these tasks. For the Calculate Drug and Product Label tasks you will need to click on the “apply” button when you are happy with your entries. When you have finished all three activities, click the exit button. Copyright © Monash University 2014

Gowning Room Before you enter the next cleanroom (product room) you will need to wash your hands and gown up. Enter the gowning room via the door on the left of the admin room. Click on the sink to wash your hands. You will need to perform the hand washing in the correct sequence. Think carefully and complete it properly. When you have finished, click on the ‘Exit Hand Wash’ button

The shelves in this room contain the items that you require to gown up for the product room. Click in the shelves to open the gowning screen and gown up.

The Product Room The product room contains shelves with all of the items that you need to complete the product. Click on the shelves (you will see the inventory screen appear) and select the items that you need and add them to your inventory. Clicking on an item more than once will add multiple instances of that item to your inventory. To remove an item from your inventory click on the item in the ‘My Inventory list’ then click on the ‘put back' button to put the item back onto the shelves. You can check items against your pick list by clicking on the pick list icon in the top corner of the screen. Pick List icon

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Transferring your items Click on the tray to put your inventory items onto it. You can transfer your items into the next cleanroom (Aseptic room) via the transfer hatch. Make sure you use the alcohol spray bottle to decontaminate your items first. You can do this by (clicking on the bench to pick up the bottle then click the mouse button when the tray is highlighted to spray the items on the tray).

Click the bench to pick up the bottle

Tray

Click on the hatch door to open it to place the items. You cannot open the door if the inner door is already open. If there is a red light showing you should close the inner door by clicking on the wall switch beside the hatch.

Gowning for the Aseptic Room Enter the next gowning room and wash your hands and gown up. Then move to the Aseptic room where you will find laminar flow cabinets (work stations) to make up your sterile product.

Using the Laminar Flow Cabinet (LFC) The view of the LFC is split to show two viewpoints. The lower viewport is interactive and shows a view from directly above. The upper viewport shows you how your items are oriented in 3d space.

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Drag the items from the bottom of the screen into the LFC. Make sure that the items are correctly placed in the LFC to maintain the laminar flow air and allow aseptic manipulations the. You can move things around after dragging them into the LFC. Notice that the area in the middle of the LFC is designated as the Work Area. This is where you will assemble items and conduct the aseptic processing activities that will result in the preparation of the product. The work area should be kept clear of non-active items. Once you have placed all your items into the LFC you will notice that buttons for processing activities appear along the bottom of the screen.

These buttons allow you to complete the preparation of the product and they function as follows: • Mix – use this button to mix two or more components. For example, after adding water to powder you will need to click ‘mix’ so that the powder dissolves in the water to form a solution. • Add – this allows you to add one component to another, for example adding water to a powder. • Draw-up – Use this to draw up fluids into a syringe. You will need to have the fluid container and the assembled syringe and needle in the work area. After clicking this button you will be asked how much fluid (in ml) you wish to draw up. • Assemble – Allows you to make up items that consist of more than one component. For example you may need to assemble a needle and a syringe to draw up solutions. • Fill – Use this button to fill a receptacle, such as a bottle or a vial with the contents of another item such as a syringe. • Seal – seals the product container. You will need to have the container, the appropriate sealing components and the crimper tool all in the work area before you can seal the product.

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For example, to assemble a syringe, you will need to drag a syringe and needle into the work area, and then click the Assemble button.

You will then have an assembled needle and syringe.

Work through the entire product preparation process in the LFC, paying careful attention to the manipulation steps you need to complete the process and volumes you use for dilutions. Disposal of items

At the end of aseptic processing in the LFC you will have a finished product which will show in a sterile bag in your display.

You will also have several items that you will need to dispose of, such as used needles, syringes and containers. Drag the scrap items to dispose of them in the appropriate way. Drag any re-usable equipment to the inventory area.

Finishing off You will need to return to the Admin Office with your finished product in order to make it available for collection. Make sure you de-gown in the appropriate places as you return to the office. You will have the opportunity to sterilise the product, if appropriate, by using either the autoclave or the hot air oven in the Product Room.

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To attach your label to the product you will need to click on the label printer.

Once labelled, Your finished product should be placed in the out-basket for collection.

To complete the exercise, return to the entry door of the exit and click it. You will be prompted to confirm your exit and can choose to cancel and return to the clean room. To complete click the complete button, which will give you marks and feedback.

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Accessing Feedback and Marks Upon completion of an exercise you will be given marks and feedback. Green feedback indicates a task that was completed correctly. Yellow feedback indicates a task that had some errors. Red feedback indicates a task that was not completed or which was completed incorrectly.

You will be able to either submit your attempt, or if you think you can do better you can start again. Exercise data is randomised, so it is unlikely that you will get the same exercise twice.

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