Cleanroom Design and Building
Our clean room engineers and designers form part of a multidisciplinary team, experienced in product scale up, facility design, containment, operations, product registration and validation.
We offer both:
- turnkey solutions, i.e. starting with market requirements, selecting process options then wrapping the clean rooms around the process, and our architects design your facility or
- we can work with your existing architect or general builder to impart our specialist clean room expertise, as needed for your next cleanroom design and construction project.
Our engineers can design and build hospital laboratories used for drug or research purposes where appropriate clean room designs are essential.
Clinical research laboratories are often conducting the first-in-human clinical studies of investigational medications on behalf of pharmaceutical and biotechnology companies. They need to comply with all international standards and the sponsor company’s requirements. These exacting requirements are a distraction task for most researchers with more important priorities. We can provide the required expertise and experience to design and build a hospital laboratory and accompanying clean room that meets all regulatory requirements as well as the process requirements of the laboratory.
If materials are developed or processed for animal or human therapy in a cGMP laboratory, the laboratory design must comply with exacting standards required by the regulators.
In addition, the laboratory design must consider typical laboratory processes, such as: sample receipt and shipping; histology; macro dissection; coding; staining; paraffin block storage; microscopy suites; cryotomy laboratories, and cryogenic storage facilities.
This is a highly specialised area that requires engineers and designers with extensive experience in order to design a laboratory that meets and will continue to meet the regulatory requirements as well as make life easier for the scientists working in the lab. Designing a lab layout that will support a logical workflow means less contamination risk, less mistakes and less stress for the people working in it.
Hospital Compounding Cleanrooms
Many hospital and pharmacy activities can only take place within a clean room. These clean rooms must meet regulatory requirements and international standards, such as ISO 14644. This standard specifies the air quality required for different clean room classifications. Our clean room designers then determine the number of air changes, the filters and the finish of the room required to achieve that air quality.
Tissue Processing and Banking Facilities
Facilities housing laboratories, clean rooms and cryogenic storage for the harvesting, processing and banking of human tissue for surgical implantation must be compliant with the TGA code of GMP for Blood and Tissue Products. This is a relatively new code, released in 2013. Consequently, there’s very little experience in Australia in building facilities that comply with the code. Our engineers have worked on Blood and Tissue facility projects since the code was released, so are knowledgeable in what can go wrong and what the TGA auditors will look for. They can help you achieve compliance cost-effectively and can prevent costly re-work on areas that turn out to be non-compliant when designed by inexperienced architects and builders.
Radiation, Imaging & Therapy Services
PharmOut has worked with a number of hospitals and facilities offering PET and other oncology radiation treatments and diagnostic imaging solutions. Some projects have included facilities for conducting clinical trials. PharmOut can be retained as your architectural, engineering or design consultant for master planning or we can design for your additions and renovations; ensuring compliance with local Building Codes and Standards (BCA and ISO) as well as the appropriate pharmaceutical regulatory frameworks.
Why Choose PharmOut?
PharmOut’s designers and engineers will help you to:
- gain greater knowledge of the product quality and building issues affecting your project
- develop increased awareness of regulatory expectations
- recognise common deficiencies and learn how to reduce them
- understand changing legislation and the complex regulatory landscape.
PharmOut are incredibly experienced in specifying the client’s critical requirements and then testing to ensure that the builder has delivered what the client requested and paid for. Our Independent Commissioning Agents, or Validation Engineers are experienced in testing critical parameters to ensure compliance.
If you would like a quote or would like to ask questions to support your next cleanroom design and construction project, please contact us.