Chapter 16 Completing Product Processing By the end of this chapter, you will be able to: l Explain the term cold chain l Describe the type of fridge used for correct storage of refrigerated products l List three factors that affect the stability of a product l Explain the reasons for using a validated transportation process l Describe how to label syringes, IV bags, infusion devices l Describe three main types of packaging used l List some of the labels you might find on transportation packaging Introduction Products can become unsafe or unusable for patients unless the correct storage conditions are maintained. A product can deteriorate in three ways: chemically, physically or microbiologically. Temperature, light and incorrect handling can all affect the stability of a product so it is very important to follow the correct storage requirements for each product. In this chapter we will look at storage, labelling, packaging and transportation of aseptic preparations. Chapter 16: Completing Product Processing 1
Aseptic Processing What do these temperature ranges mean? Some products are stored at a temperature of up to 25 C This is referred to as room temperature or ambient temperature. The temperature of storage areas needs to be controlled and monitored as it can fluctuate throughout the year depending on the outside temperature. The majority of products, once prepared, require a temperature of 2 to 8 C and so must be stored in a fridge. When a product is refrigerated, it significantly slows down microbial growth which can reduce the risks for patients. The Cold Chain When an item that requires refrigeration is made, it is important to ensure that the product stays under the right conditions to maintain its integrity until it is required by a patient. This control process is called the cold chain. The temperature must be maintained within acceptable limits throughout the transport process. Products that need refrigeration can deteriorate if they are not stored at the correct temperature and therefore must be placed in a fridge as soon as possible after preparation. Refrigerated products are delivered to clinical areas in a cool box or bag with a cool pack and are placed in a fridge again as soon as possible after delivery or at the point of delivery. Refrigerated items should be removed just prior to use and any unused items returned to the fridge as soon as possible. Information: Products should not be administered to patients immediately from the fridge. They should be allowed to warm up to room temperature. Shelf Life The shelf-life of a product should reflect its intended use and administration and should take into account, for example, prolonged storage at skin or body temperature. Some products that are stable at room temperature can be refrigerated to decrease the risk posed by potential microbial contamination. Information: You must check the manufacturer s instructions. Stability Many sources of information about stability exist and it is the responsibility of the pharmacist in charge of the facility to ensure that the information used in stability determination is scientifically valid and accurate. Suitable data should be sought and evaluated before products are prepared. Stability should be assessed to ensure that the quality of the product is suitable for the patient at the time of administration. 2 Chapter 16: Completing Product Processing
Chapter 16 Completing Product Processing Test Yourself Complete the following sentences: A product can deteriorate in three ways:., or......,..... and... can all affect the stability of a product. Correct Refrigeration The fridge used for storage must comply with certain requirements and be suitable for use. Products should be spread out in the fridge, to aid circulation of cold air around them and hence to speed up and increase the efficiency of chilling. Products should be chilled prior to transportation, except if the time between preparation and delivery to the point of use is minimal. Chilling should be for a minimum of 4-6 hours to effectively cool the whole contents of the container. Temperatures should be read and recorded daily. A fan-assisted fridge is required a domestic fridge is not suitable for use! The movement of air in the fan-assisted fridge will decrease the chances of hot and cold spots. The temperature of the product will be brought down more rapidly. The fridge needs to have much larger capacity than the amount that is intended to be placed in it. This will allow for air circulation and to ensure that the fridge is not running to maximum capacity all the time. The temperature should be monitored constantly. A maximum/minimum thermometer should be placed in the fridge to show if the temperature limit has been exceeded or if the minimum temperature has not been reached. Chapter 16: Completing Product Processing 3
Aseptic Processing All fridges used to store pharmaceuticals need to be temperature mapped annually. This is to show that all parts of the storage area stay within the design limits of 2 o C to 8 o C. Fridge temperature records should be maintained either electronically or manually. These records should be held for at least 1 year and in some cases longer. (See your local procedure). Effect of Light Task List five products that need protection from light: 1. 2. 3. 4. 5. Light can damage some pharmaceutical compounds and this is especially true of natural light which is of higher energy than artificial light. List five ingredients that need to be stored between 2 o C and 8 o C: 2. 3. Photodegradation is a problem for pharmaceutical compounds in solution and it is usual practice to protect all products from light wherever possible during storage and distribution. Some products are so light sensitive that they require protection from light during administration. 4. 5. 4 Chapter 16: Completing Product Processing
Chapter 16 Completing Product Processing Transportation Products should be distributed using a validated process to ensure the cold chain is not broken and to ensure the product is suitably protected during transportation. Hazardous products such as cytotoxics should be handled carefully to prevent damage and leakage, to avoid harm to those handling them. Items not requiring refrigeration should be sent via a validated transport mechanism which protects the product during transportation and ensures product quality upon delivery. When transporting products that require refrigeration, the temperature of the products must be maintained within acceptable limits throughout the transport process. This can be achieved by using cool boxes and cold packs. Correct Labelling After a product has been visually checked it should be labelled. Before starting the labelling process: l the area should be clean and free from other products; l the area should be free from other labels l Line clearance or bench clearance logs are used to record this. l One product should be processed at a time to avoid a mix up. When labelling syringes some general guidance is: These boxes may be colour coded to show they contain for example Parenteral Nutrition solutions or cytotoxic drugs. l 1-10ml syringes should be flagged around the barrel of the syringe. Whatever the method of distribution, the container must be moved safely, maintaining the cold chain and the integrity of the product. On receipt of refrigerated items, the products should be unpacked and immediately refrigerated, prior to use. l 20-50ml syringes should have the label on the barrel parallel to the graduations. Chapter 16: Completing Product Processing 5
Aseptic Processing l It is good practice to arrange the label on the syringe with the plunger to the right of the text. (Most people are right handed and this means the label is most easily read). When labelling infusion bags: IV Bags should have the label placed over the original contents of the bag but not covering the name of the base solution. The text on the label should be in the same direction as the text on the infusion bag. The label should not cover critical information, such as warnings. Once the product has been labelled it should be placed in an area designated for final checking. l Don t forget the documentation! l The number of labels used should be recorded on the label reconciliation section of the worksheet. l Any unused labels should be documented, defaced to prevent further use and placed in the plastic sleeve. (Check your local procedures.) After final checking the different product types must continue to be segregated. This means cytotoxic products, Parenteral Nutrition products and CIVA are all kept separate. All products should be stored under refrigeration unless it would be detrimental to the product to do so. Batches of the same product that have been produced at the same time should be stored together. Packaging There are three main types of packaging. Infusion devices should have the label in an appropriate position to ensure that it can be clearly seen and read. The label should not cover any critical information on the device. 6 Chapter 16: Completing Product Processing Primary Packaging Packaging which has direct contact with the product. This should be suitable for purpose and should ensure that the product remains fit for use. For example, PVC bag, *Ethylene-vinylacetate (EVA) bag, polypropylene syringe, etc. The primary packaging must be compatible with the product and not release anything into it. *Ethylene-vinyl-acetate is a type of plastic, used for its good compatibility with Parenteral Nutrition ingredients
Chapter 16 Completing Product Processing Transport packaging Products should be transported in rigid, leak proof containers capable of containing spills and maintaining the cold chain when required. Containers should be clearly marked with the destination and originating department. Tamper evident seals should also be used where possible. Secondary Packaging This is not in direct contact with the product. This adds further protection to the product and enables a second patient label to be added. Products should be protected from light and damage. Common practice is to overwrap the product with clear polythene to prevent leaks and enable people to read the label. Secondary opaque packaging can be used as light protection and can be colour coded to aid identification in clinical areas. Heat sealing also provides a tamper evident seal and can prevent leaks. Supplementary labelling can be added to the secondary packaging e.g. cytotoxic hazard label, additional storage requirements, order of use labels. Dark outer packaging is used when the product needs to be protected from light. Cytotoxic products require specific packaging to highlight the need for safe handling. For cytotoxic products, transport boxes should contain emergency contact information and instructions for safe handling in case of spillages. Chapter 16: Completing Product Processing 7
Aseptic Processing Further Reading: Refer to Chapter 19 Cytotoxic Preparation for more information on transporting cytotoxic preparations. An indication of the storage temperature must be displayed when refrigeration is required. An indication of the storage temperature must be displayed when room temperature storage is acceptable. Flat packaging is used for products that need to be stored flat. A CD sticker must be applied for controlled drugs that have to be locked in a CD cupboard. 8 Chapter 16: Completing Product Processing
Chapter 16 Completing Product Processing Activity Make sure you watch the following videos at: http://www.medslearning.leeds.ac.uk/pages/aseptics/videos.html and then refer to your local procedures: l Labelling a 1ml syringe video 21 l Labelling a 10ml syringe video 22 l Labelling a 50ml syringe video 23 If there are any variations in your local procedures, make a note of them below. Chapter 16: Completing Product Processing 9
Aseptic Processing Questions Q1 Explain what we mean by the Cold Chain and why it is important to maintain this chain. (4) 1. Q2 List three factors that can affect the stability of a product and steps you can take to protect against them. 2. 3. 10 Chapter 16: Completing Product Processing
Chapter 16 Completing Product Processing Q3 1-10ml syringe: What are the rules for labelling each of the following? 20-50ml syringe: IV bags: Infusion devices: Chapter 16: Completing Product Processing 11
Aseptic Processing Q4 Name and describe the purpose of three main types of packaging. (6) 12 Chapter 16: Completing Product Processing