Aseptic Services Unit

Our quality commitment is resolute and includes implementing Good Manufacturing Practice (GMP) across all our processes.

Eurolab’s state of the art sterile cGMP facility improves access to quality oncology treatments

Eurolab’s Aseptic Services Unit (ASU) is located in Midrand, Johannesburg, and has a core business focus on centralized sterile oncology admixing. It is South Africa’s first centralised sterile admixing facility and is modelled on international best practice facilities in the United Kingdom, Europe and Australia. Its centralised admixing facility offers significant benefits to both oncologists and patients across South Africa by improving access to quality assured chemotherapy. The ASU offers a centralised mixing service for sterile oncology medicines, the preparation of advanced therapeutic medicinal products and the preparation of sterile clinical trial medicines.

“Our Aseptic Services Unit is aligned with universal health access programmes such as the UK’s National Health Service (NHS). We do not compromise on quality and enhance the practice of pharmaceutical care to achieve improved patient treatment outcomes. In SA, we are a collaborating centre for the University of Witwatersrand and the University of Pretoria.” – Gavin Steel.

ASU – Benefiting oncologists and their patients

Our clients enjoy the following benefits:

  • Reduction in patient waiting times
  • Reduction in medication errors
  • Ongoing security of oncology medicine supply
  • Mitigation of health and safety risks associated with the handling of chemotherapy medicines
  • Each product is issued with a certificate of compliance (COC) for sterility
  • Extended stability allows for centralised admixing and administration at infusion sites and home- based care.

These benefits enhance the practice of pharmaceutical care and contribute to improving patient treatment outcomes.

Linah’s Journey

Linah Dizende is just one of the thousands of South Africans living with cancer, desperately in need of oncology medicine (chemotherapy) but unable to access treatment and care at a nearby healthcare facility. Chemotherapy infusions are not offered at all District Hospitals and Primary Healthcare Centres, especially in remote areas.

Patients must use public transport to travel long distances, at their own expense, to reach facilities that do. In some cases, patients may have to sleep on benches overnight. After treatment, patients face the long and exhausting journey back home.

The difficulty experienced in accessing treatment often results in patients choosing to forgo or abandon treatment, often leading to poor patient outcomes.

Aseptic Services Unit (ASU) aims to change this. The ASU is a state-of-the-art facility in Midrand, Johannesburg. At ASU Africa, chemotherapy bags are safely mixed on site and tested for sterility and stability.

The pre-mixed bags can be transported to facilities, no matter where they are, where nurses can seamlessly deliver the infusions. For all patients like Linah, The ASU is committed to providing accessible, quality oncology solutions with the aim of positively impacting their quality of life and helping to improve treatment outcomes.

Join us on the road to providing accessible quality oncology solutions to all South Africans.

Consent has been obtained from all interviewees in the video.

Our Services

Centralised admixing service for cytotoxic and biological medicines
Management and preparation of sterile clinical trial medicines
USP 797

USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. USP is a not-for-profit, science-driven organization based in the United States that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.

Our Clients

  • Doctors who want their patients to access sterile oncology medicines that require admixing which meets international best practice quality and safety standards.
  • Clinical trial sponsors and principle investigators requiring compliance to international best practices for sterile admixing as set out in USP 797 ensuring quality and safe oncology medicines.
  • Contract manufacturers who can use our world class GMP-approved facility for contract manufacturing.
  • Medical schemes seeking optimal efficiency for expensive medicines.

Specialised Equipment

Our fully validated facility is compliant to cGMP (Manufacture of Sterile Medicinal Products) as set out in the SA Guide to Good Manufacturing Practice for Medicines. It encompasses:

  • A GMP-approved cleanroom with biosafety cabinets (Grade A) in a Grade B background environment
  • Specialised cameras which ensure photographic evidence of each admixed product and forms part of the documented evidence to ensure complete batch traceability
  • Fully validated, innovative rapid microbiological testing technology which provides sterility confirmation within 4 hours, allowing for the release of product within 24 hours.

The Team

We are a highly skilled team with staff who are trained in handling sterile product and aseptic technique. We have an in-depth pharmaceutical knowledge as well as an understanding of product and process requirements for sterile oncology medicine preparation. Our fully equipped microbiological laboratory is headed up by a team of highly skilled microbiologists with extensive experience in the sterile pharmaceutical industry.

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