Aseptic Preparation and Dispensing of Medicines 2019

By Hamish Hogg

Andrew Barrow and I attended the Aseptic Preparation and Dispensing of Medicines (APDM) course on the 9th and 10th July 2019 at Leeds Trinity University. Cherwell Laboratories Ltd were exhibiting along with other companies and manufacturers involved in the Pharma industry on day two and three of the four- day course.

The APDM Continuing Professional Development course has been jointly organised by NHS Technical Specialists Education and Training Group (NHS TSET) and the University of Leeds and is designed to:

  • Meet the needs of pharmacy staff (pharmacists and experienced senior technicians) who are engaged in the aseptic processing of medicines
  • Cover the principles and practice of asepsis
  • Provide an update on knowledge of standards, practices and quality assurance arrangements relating to the aseptic preparation and dispensing of medicines

The course is presentation based with discussion groups on three afternoons.

I was able to attend a couple of lectures and a workshop to understand the difficulties observed, required knowledge and techniques for aseptic preparation in NHS pharmacies. The course organisers and presenters had a great ethos of an open-door policy to allow learning, for not only the delegates but the exhibitors as well.

Design and Function of Cleanrooms

I attended a presentation from Malcolm Thomas, a Consultant Engineer, on ‘Design and Function of cleanrooms’. He started with the old standard for cleanroom BS5295:

“A room with control of particulate contamination, constructed and used in such a way as to minimise the introduction, generation and retention of particles inside the room and in which temperature, humidity and pressure shall be controlled as necessary.”

It has been withdrawn and replaced with ISO 14644 (1-14) 2015, but Malcolm uses the old standard to prompt the technicians to ask the question: is their facility constructed as a cleanroom so it can be used as a cleanroom? If there are big double doors to the outside and the statement from the technician is ‘it is a cleanroom when the doors are closed after deliveries’ then there is a serious issue!

The standard mentions temperature, humidity and pressure, that allows staff to work in the best environment possible. This means that they don’t shed as many particulates and find it comfortable to work in. Therefore, lowing the risk of contamination to the environment and particle count. Supply of air and volume can also be used to dilute particulates aiding that controlled environment. Even though the standard has been updated and harmonized the premise is still the same.

Malcolm then moved to classification and grading but presented the regulation for each classification as a tool to create a cleanroom that is fit for their purpose of manufacture and end product.

Practical Considerations in the Management of Critical Workstations

I also attended the presentation by Chris Watts, ‘Practical Considerations in the Management of critical workstations’, firstly stating that aseptic preparation is the highest risk in pharma production, providing probability of contamination:

  • SAL for terminally sterilised products is 1 in 1,000,000
  • SAL for aseptic products is 1 in 1000

Emphasising the need for adequate education and training, but also leading into management of work zones and staff that would reduce the risk of contamination:

  • Ensuring the correctly trained individuals are in the right location and aiming to retain knowledge and understanding of these experienced individuals. This also touched on what was stated at the PHSS conference in my previous blog, emphasising that this loss of experience happens across the industry.
  • Aiding your staff to perform at their best ability, for instance using ergonomic isolators to reduce upper limb disorders.

Managing the area sometimes requires flexibility and insight as a patient need might override guidance (not regulation), but guidance in product manufacture. For example, for possibly multiple reasons, aseptic products for patients may have to be manufactured and packaged in one isolator rather than two separate isolators in an NHS pharmacy, so long as the process has been risk assessed and a methodology validated.

Cross department experiences have been a vital tool in understand why aseptic prep is so vital. Therefore, sending a technician to a ward round and seeing the patients that they may affect if not performing to the best of their ability or not being aware of checks and procedures, brings home an understanding of purpose to their work. Putting forward the alternative of bringing nurses into the pharmacy to understand what technicians need to perform their job role effectively was also included.

Opening lines of communication, encouraging conversation, empowering staff with a no blame policy allows the development of the cleanroom environment and a better workspace.

Aseptic Technique for Aseptic Transfer Workshop

I had the benefit of attending a workshop on aseptic technique for aseptic transfer. Tim Sizer was leading the workshop discussing historical major incidents that led to educational courses and standards. Emphasising the awareness that a patient can be affected if it goes wrong.

He continued about how to maintain sterility and no touch technique, exercising risk management and risk reduction through controlled parameters and good technique. The need for supervision, if necessary, and monitoring of staff through training records.

Tim then discussed GMP annex 1 and MHRA guidance on the reasons for spray in and understanding that there is a cleaning and an inspection process. Asepsis is a continuum across departments from quality control of a manufactured product from a supplier, to storage, to the filing line of the pharmacy and the inspection of the product by professionals, before being administered to the patient.

There are limitations to certain cleaning methods such as gas sterilisation and certain materials may become more of a risk. For instance, plastic can hold a static charge allowing for the attachment of more dust and dirt particles.

Tim did point out the benefits of terminally sterilised triple wrapped product for aseptic transfer. It reduces the use of sporicidal disinfectants and alcohol sprays used by the technician, as all they do is remove a layer of packaging and transfer the item, reducing the time in processing. It may be a more expensive item, but savings can made elsewhere when implementing this solution. 

During the breaks of the day the delegates had a chance to come around and interact with the exhibitors. The delegates ranged from NHS Technicians, Senior Technicians, Pharmacists to Quality Control Managers, all keen to come and interrogate us….I mean discuss our product. The delegates were positive and clearly keen to learn what was available to them to aid their cleanroom environment. Andrew and I relished the interaction between new and current customers, actively asking about the company, our products and the service we aim to provide.

The 2 days were an interesting insight to aseptic preparation and dispensing of medicines in the NHS environment and was a positive experience and interaction with professionals from the NHS and other exhibitors.

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