Eurolab’s state of the art SAHPRA-approved 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 South African Health Products Regulatory Authority (SAHPRA)-approved centralised sterile admixing facility and is modelled on international best practice facilities in the United Kingdom, Europe and Australia. Its centralized 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, GM of Eurolab’s ASU.
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.
Centralised admixing service for cytotoxic and biological medicines
Management and preparation of sterile clinical trial medicines
Manufacture of ATMP’s such as CAR-T
ADVANCED THERAPY MEDICINAL PRODUCT (ATMP)
Advanced Therapy Medicinal Product (ATMP) is classed as either a gene- or cell-therapy and includes tissue-engineered medicinal products. ATMPs are medicinal products that alter a person’s genes or cells to bring about a desired therapeutic effect.
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.
- 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 of ATMPs.
- Medical schemes seeking optimal efficiency for expensive medicines.
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.
“Our business is based on international best practice as followed in the United Kingdom, Europe and Australia. We are aligned with key guidelines including the MHRA Guidance for Specials Manufacturers (UK) and the Compounded Medicines and Good Manufacturing Practice (GMP) (Australia).”- Gavin Steel, GM.
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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