Independent Aseptic Compounders
Independent Aseptic Compounders manufacture aseptically prepared injectable solutions which are used to meet specific patient needs in the treatment or management of a range of diseases, disorders or medical conditions. These solutions include chemotherapy, parenteral nutrition and Central Intravenous Additive Services (CIVAS), and are often referred to as ‘specials’.
What is aseptic preparation?
Aseptic preparation is the manipulation of sterile starting materials and components in such a way that they remain sterile and uncontaminated whilst being prepared for presentation in a form suitable for administration to patients. Aseptic techniques aim to prevent pathogenic organisms from being introduced to susceptible sites by the user, environment or equipment. IV solutions are prepared using carefully defined aseptic techniques and processes to avoid contamination. These techniques and processes are performed in high-grade cleanrooms where measures such as clean clothing, non-touch techniques and environmental air filtration are implemented.
Independent Aseptic Compounders produce three main types of IV solutions:
- Chemotherapy: Chemotherapy is the use of cytotoxic (anti-cancer) medicine to treat a disease.
- Parenteral Nutrition (PN): PN is the provision of nutrition to patients intravenously (via the veins) in the form of a liquid infusion.
- Central Intravenous Additive Service (CIVAS): CIVAS include any preparation which is manipulated aseptically to create a ready-to-use injectable medicine, e.g. antibiotics or pain relief.
The value of the sector
The Independent Aseptic Compounders sector is a valued partner of the NHS and plays a key role in ensuring that patient specific treatment needs are met. Some NHS Trusts posses the infrastructure and capacity to meet all or some of their aseptic requirements. Where they do not, the preparation of specials is outsourced. The Independent Aseptic Compounders provide additional aseptic capacity and relieve pressure on the NHS; the sector is proud to support patients in partnership with the NHS.
Regulation
All Independent Aseptic Compounders hold a manufacturing specials licence issued by the MHRA – the UK body responsible for the regulation of medicines and medical devices. This licence permits the compounding of medicines which are referred to as ‘specials’. Specials are manufactured specifically at the request of a prescriber when there are no suitably licenced medicines available that will meet a specific patient’s needs. To ensure that these specials are safe and efficacious, manufacturers comply with relevant legislation and guidance, and are subject to regular inspections by the MHRA to maintain high quality standards and retain their manufacturing specials licence.
For more information, download BSNA's 'A Guide to Independent Aseptic Compounders' here.
