unit 209 assist with the preparation of aseptic products 209.pdf · unit 209 assist with the...

Unit 209 Assist with the preparation of aseptic products

NVQ Level 2 Pharmacy Services award Underpinning Knowledge Manual

Element 1 Assist with the preparation and packaging of aseptic productsElement 2 Assist in the completion of the aseptic process

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Element 1 Assist with the preparation and packaging of aseptic productsElement 2 Assist in the completion of the aseptic process

Background

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Certain products that are made in the pharmacy production area will need to be sterilised. Theseproducts could be for injection into the body or to be applied to delicate areas such as the eyes.Sterilisation of a product ensures that it is free from contaminants and bacteria.

Where possible products should be sterilised using a special sterilisation process that heats theproduct to a very high temperature; this is called terminal sterilisation.

Some products cannot be sterilised in this way as the high temperature of the sterilisationprocess harms or affects the ingredients of the product. This could cause the pharmaceuticalingredient to be destroyed therefore making it ineffective, or it may reduce the strength of theproduct. This is because some ingredients are unstable when heated.

However these products still need to be sterilised. This is done through a special process calledaseptic technique.

Sterilisation by aseptic technique is when the prepared product, usually a solution, is passedthrough a very fine filter, which takes out any micro-organisms and foreign matter, such as particles. Performing this technique is a skilled process, as it needs to ensure and minimise therisk of the operator introducing contamination into the process.

Aseptic preparation should only be used when other methods cannot be used since it providesonly the lowest level of sterility assurance. At all times there must be strict adherence to GoodManufacturing Practice for Human Medication: Rules and Guidance 1997. As with all other areas ofpharmacy adherence to Standard Operating Procedures (SOPs) is essential and any deviation from aSOP must not occur unless the authorised person within the unit has approved it in writing.

To help ensure the product is sterile the aseptic procedure is carried out in a very clean environment. It is conducted in a clean room under a laminar flow cabinet or in an isolator.

Under the National Quality Assurance guidelines for aseptic preparation, the aseptic procedurestarts with using sterile materials. This includes all the ingredients and equipment. As an extraprecaution these are sprayed with 70% Industrial Methylated spirit before they are introducedinto the clean room where the procedure will take place.

The clean room environment is protected by air filters, and by controlling the flow of air withinthe room. Air pressure inside the room is regulated to ensure that when doors are opened, theroom is still protected from dust and dirt that could enter.

All staff working in the clean room wear sterilised protective clothing, including hats, clothes andmasks, as well as overall body suits. There are special procedures to follow for gowning up andentering the clean room.

The products that are prepared by aseptic technique procedure could include:

Parenteral Nutrition (PN) This is when a patient is fed straight into the veins, by-passing the digestive system

CIVAS Centralised Intravenous Additive Service

PCA Patient Controlled Analgesia

Topical preparations Sterile products such as eye drops



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Some of these products are made in a laminar air cabinet but some need extra precautions forboth the product and the operator. Products such as Cytotoxic preparations are made in a special cabinet called an isolator.

Aseptic units vary in size, the products prepared in them and the services they are able to provide. Many units are licensed by the MCA (Medicines Control Agency) to provide a full manufacturing service while others are not. It is important that you should be able to distinguish between them.

Before starting work in the aseptic preparation unit it is important to understand the principlesof Good Manufacturing Practice (GMP) for preparing aseptic products. These include the importance of monitoring the 'clean' environment and workflow patterns, procedures for 'gowning up', preparing ingredients and equipment as well as preparation techniques and therequirements for completing the process and the documentation.

Key words and conceptsThese definitions are provided to explain how key words and concepts are used in this unit

Cytotoxic drug used in the chemotherapy treatment of cancer. They can have both anti-cancer activity and the potential for damage to normal tissue.

Aseptic technique a technique for preparing products from sterile ingredients without introducing any microbiological contamination to occure.g. coming into contact with the operator's hands or the environment.

Parenteral nutrition is an intravenous mixture of nutrients in appropriate combinationsfor the patient, providing the sole source of nutrition.

Pharmaceutical a cabinet device that uses barrier technology for the enclosure Isolator of a controlled workspace.

Laminar air flow an open workstation with air supplied through HEPA filters andcabinet the air moving in one direction, either horizontal or vertical.

HEPA filters High Efficiency Particulate Air filters, which are used to removeparticles from the air.

Official guidelines this includes the Aseptic Dispensing for NHS Patients (Farwell Report), Rules and Guidance for Pharmaceutical Manufacturersand Distributors (GMP), Isolator guidelines, Quality Assurance of Aseptic Preparation Services.

MCA Medicines Control Agency - The government agency responsiblefor licensing of products and manufacturing areas and subsequent audit of the premises and product.



Knowledge and Understanding

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You must show that you know and understand:

For the whole unitK1 Basic principles of Good Manufacturing Practice.

K2 Current relevant Health and Safety Legislation and how it applies to the working environment, including COSHH.

K3 The importance of SOPs and why you must always work within these procedures.

K4 Basic hygiene and the importance of maintaining a clean working environment.

K5 The importance of personal hygiene and the correct use of protective clothing.

K6 The reasons for using and keeping the correct documentation.

K7 The limits of your own role and the referral procedures.

K8 The sources of contamination and the appropriate corrective action

Preparation and packaging of aseptic productsK9 The difference between the various types of products.

K10 How and when to use the different processes.

K11 The correct handling of hazardous materials and how to minimise the risks.

K12 How to carry out accuracy and quality checks and why they are important.

K13 The importance of label and product reconciliation.

K14 The methods and materials used for packaging.

Completing the processK15 The procedures for dismantling equipment.

K16 The different methods of cleaning equipment and work areas.

K17 How to store equipment safely and in a condition ready for use.

K18 The procedures for the safe disposal of equipment, waste materials and cleaning products.

K19 Procedures for quarantining products and when this applies.

K20 The importance of storing products correctly including temperature conditions.



Activities

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1. Find out and where your procedures for the preparation of aseptic products are kept.Read the procedures listed above before training.Discuss key points with your Trainer/Assessor.

2. Draw a 'family tree' and add in the name of all the staff in your aseptic unit. Record and describe the job titles of all staff identified on the 'family tree'.Discuss with your Trainer/Assessor your role, your limits and responsibilities of your work.Identify who you should refer to if you need advice, help or guidance on any part of your work.

3. Draw and label a plan of your unit.

4. Find out and briefly describe how air is processed before it enters the aseptic section, including how dirty air is prevented from contaminating it.Add to your plan airflow patterns.Find out which "class" your aseptic room complies with if appropriate.

5. Discuss with your Trainer/Assessor what GMP means, what 'section 10' ofthe Medicines Act is and how this is applied to your unit.Briefly describe the points covered.

6. Find out what is meant by "cross contamination". List the causes, consequences and measures to prevent this occurring.

7. Find out which products are manufactured in the aseptic section,e.g. named patient "specials" and aseptic topical preparations.

8. Explain the following terms (your Trainer/Assessor may wish to add to this list)a) PNb) TPN c) PCA

9. Discuss with your Trainer/Assessor why a patient may need to be given PN or TPN.Some hospitals have nutrition teams. If your hospital has one ask if you can visit a PN patient with the team. See how PN is administered to this patient.

10. Find out how to ensure that the working environment has been maintained. Find out how it is monitored and what records are kept.Ask your Trainer to observe you carrying out the daily and weekly monitoring.



Activities

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11. Find out where all equipment, materials and disposable items are stored.Find out how these must be prepared before entry to the clean room and howyou ensure the equipment is as clean as possible. Explain to your Trainer/Assessor why must this process be followed.Find out and describe how to replace raw materials and stocks once they have reached the minimum stock level.

12. Receive training in the 'spraying in' process and get it validated.Explain to your Trainer/Assessor what validation means and how it is carried out.

13. Describe how each area is cleaned and prepared before any aseptic preparation can take place.Find out when the aseptic section is cleaned, by whom and which disinfectants are used.Find out if the cleaning fluids are rotated and describe which disinfectant is used to prepare equipment for entry into the clean room.Obtain a copy of your departmental surface disinfectant procedure.

14. Find out what final checks are made to these products before release. Find out who is responsible for final release of these products prior to use by the patient.Find out how the documentation for these products is stored.

15. Describe the process for cleaning down after the aseptic process has finished.Find out what rules govern the waste disposal of pharmaceutical agents, and what SOPs are in place in your department for this process.

16. Describe the clothing requirements for:a) Clean roomsb) Parental nutritionc) Cytotoxicsd) IV additives (CIVAS)

Discuss the reasons for any differences with your Trainer/Assessor.

17. Find out how garments are laundered and sterilised for your unit. Find out what documentation is used for this process and how to complete it (if applicable). Keep a copy for your portfolio.

18. List the final checks made to products before release. List who is responsible for final release of these products prior to use by the patient.Find out where the documentation for these products is stored. Keep copies for your portfolio.



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Activities19. Observe and participate in the process for cleaning down after the aseptic

process has finished. Find out what rules govern the waste disposal of pharmaceutical agents, and what SOPs are in place in your department for this process.

20. After training, ask your Trainer/Assessor to discuss the following with you:a) How labels are producedb) When producing labels for batches or products how the number of labels

produced is controlled c) What details have to be printed on the label d) Whether your labelling system is computer controlled e) Who is allowed access to the system

21. Find out if you use pre-printed worksheets. If you do, write an explanation for each piece of information required on it.

22. Discuss with your Trainer/Assessor the requirements necessary for batch sheets, pre-printed and blank worksheets.Find out if you use a batch numbering system. If you do, find out how each number is obtained and recorded. Find out why batch numbers are used.

23. Discuss the necessity of expiry dates on aseptic products and why the majority of aseptically prepared products are refrigerated.

24. Find out what quarantine is. Discuss the following points with your Trainer/Assessor:a) Whether any of the products you make are subject to quarantineb) What happens to the product whilst in quarantine c) What documentation accompanies this processd) How long is this documentation stored for

25. Find out if you have a recall procedure in place. If so, how it is put into place?

26. Find out what microbial tests will be performed during the manufacturing process.

27. Discuss how aseptic technique is validated. Discuss with your Trainer/Assessor the reasons for operator validation. Are your processes validated?If so, how and why is this done?If not what are the reasons for not doing so?Ask your Trainer/Assessor to validate your aseptic technique.



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Activities28. Find out what can cause aseptic products to degrade and what problems can

occur if the products were given to a patient.

29. Discuss which products that you make are considered 'hazardous'. Discuss how COSHH regulations are followed to minimise danger from these products. Discuss how spillages from these products would be dealt with.Discuss the general COSHH documentation process for your unit.



Questions

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K1 Basic principles of Good Manufacturing Practice.

� What are the basic principles of Good Manufacturing Practice (GMP)?

� How does GMP apply to your working environment?

� Why is it important that you follow the principles of GMP at all times in your working environment?

� What could happen if you did not follow the principles of GMP?



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QuestionsK2 Current relevant Health and Safety Legislation and how it applies to the working

environment, including COSHH.

� What are the key points covered in the Control of Substances Hazardous to Health (COSHH) Regulations 2002?

� How does this COSHH legislation apply to your working environment?

� Why is it important that you follow this COSHH legislation?

� What could happen if you did not follow this COSHH legislation?



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(continued)

K2 Current relevant Health and Safety Legislation and how it applies to the workingenvironment, including COSHH.

� What other Health and Safety Legislation and procedures are in place in your organisation and department, which are relevant to your working environment?

� What are the key points covered in these documents?

� Why is it important that you follow this legislation/these procedures?

� What could happen if you did not follow this legislation/these procedures?



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QuestionsK3 The importance of SOPs and why you must always work within these

procedures.

� What is meant by aseptic dispensing?

� What procedures are in place in your department relating to the preparation of aseptic products?

� What are the key points covered in these procedures?

� Why is it important that you follow these procedures?

� What could happen if you did not follow these procedures?



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QuestionsK4 Basic hygiene and the importance of maintaining a clean working environment.

� Why is it important to maintain a clean working environment?

� What could happen if a clean working environment was not maintained?

� How is the cleanliness of your working environment maintained?

� How is the cleanliness of your working environment monitored?



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(continued)

K4 Basic hygiene and the importance of maintaining a clean working environment.

� What are your roles and responsibilities in maintaining a clean working environment?

� What are the roles and responsibilities of the other members of your team in maintaining a clean working environment?

� What is meant by a clean room?



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QuestionsK5 The importance of personal hygiene and the correct use of protective clothing.

� What procedures are in place covering personal presentation and hygiene in your workplace?






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(continued)

K5 The importance of personal hygiene and the correct use of protective clothing.

� What protective clothing are you required to wear in your workplace?

� Under what circumstances must you wear this protective clothing?

� Why is it important that you wear this protective clothing in these circumstances?

� What could happen if you did not wear this protective clothing?



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QuestionsK6 The reasons for using and keeping the correct documentation.

� Which pieces of documentation do you use in your workplace?

� What are the purposes of these pieces of documentation?

� Under what circumstances do you use these pieces of documentation in your workplace?



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(continued)

K6 The reasons for using and keeping the correct documentation.

� What records must be kept in your workplace?

� Why is it important that these records are accurately maintained?

� What could happen if these records were not accurately maintained?

� What are your roles and responsibilities in maintaining these records?

� What are the roles and responsibilities of the other members of your team inmaintaining these records?



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QuestionsK7 The limits of your own role and the referral procedures.

� What are your roles and responsibilities relating to the preparation of aseptic products?

� What are the roles and responsibilities of the other members of your team who are involved in the preparation of aseptic products?

� Under what circumstances would you refer to each of these team members when preparing aseptic products?



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QuestionsK8 The sources of contamination and the appropriate corrective action.

� What is meant by the following?- Contamination- Microbiological contamination- Cross-contamination



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(continued)

K8 The sources of contamination and the appropriate corrective action.

� What are the basic causes of contamination in your workplace?

� How can these sources of contamination be avoided?

� How should you deal with areas that are contaminated?



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QuestionsK9 The difference between the various types of products.

� What different types of products are made in your unit?

� What are the differences between these types of products?

� What is your role in making these products?



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QuestionsK10 How and when to use the different processes.

� What processes are used in the preparation of aseptic products in your unit?

� Under what circumstances are these different processes used?

� What is the reason for using these processes in these circumstances?

� Why is it important that these processes are carried out accurately?

� What could happen if these processes are not carried out accurately?



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QuestionsK11 The correct handling of hazardous materials and how to minimise the risks.

� What hazardous materials do you come into contact with in your job role?

� How can you identify these materials?

� How should these materials be handled?

� What precautions must you take to minimise the risks associated with these hazardous materials?



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QuestionsK12 How to carry out accuracy and quality checks and why they are important.

� What procedures are in place in your department relating to the accuracy and quality checks which need to be carried out during the preparation of aseptic products?






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QuestionsK13 The importance of label and product reconciliation.

� Why is it important to reconcile all labels that have been generated?

� What could happen if this did not occur?

� Why is it important to reconcile all products that have been used in the aseptic preparation process?

� What could happen if this did not occur?



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QuestionsK14 The methods and materials used for packaging.

� What methods and materials are used for packaging the aseptic products prepared in your department?

� For which aseptic products are these methods and materials used?

� Why are these methods and materials used for these products?



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QuestionsK15 The procedures for dismantling equipment.

� What procedures are in place in your department relating to the dismantling of equipment after use?






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QuestionsK16 The different methods of cleaning equipment and work areas.

� What procedures are in place in your department relating to cleaning equipment and work areas after use?






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QuestionsK17 How to store equipment safely and in a condition ready for use.

� What procedures are in place in your department on how to store equipment safely and in a condition ready for use?






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QuestionsK18 The procedures for the safe disposal of equipment, waste materials and

cleaning products.

� What procedures are in place in your department relating to the disposal of waste materials and cleaning products?






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QuestionsK19 Procedures for quarantining products and when this applies.

� What procedures are in place relating to the quarantine requirements for aseptic products which have been prepared in your department?






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QuestionsK20 The importance of storing products correctly including temperature conditions.

� What procedures are in place relating to the storage of aseptic products which have been prepared in your department?




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