In conjunction Guardtech Group Design Team have engineered a specially tailored pre-fabricated, portable cleanroom solution for rapid deployment that enables NHS Trusts to mobilise aseptic pharmaceutical compounding within a GMP environment, compliant with latest updated Annex 1 guidance.
The solution provides full consideration for planning, site enablement, NHS HTM03-01 compliance and process flow as well as all necessary furniture & equipment such as isolators, transfer hatches and associated utilities.
Cleancube Aseptic Pharmacies Isolator Integration
Typically, the heart of the process, isolator selection is fundamental for these critical environments. Guardtech work with a number of manufacturers to incorporate isolators that best meet your process demands and user preferences.
- Range of isolator manufacturers
- Pre-installed at manufactured facility
- Extraction and ventilation incorporated
- VHP transfer protocol considered
- Fully commissioned with ongoing Service Contract
Cleancube Aseptic Pharmacies Changing Arrangement
The recent changes to Annex 1 guidance have resulted in an increased consideration for changing spaces between grades and separated room entry and exit. Guardtech have crafted some intelligent workarounds to ensure compliance whilst minimising impact on footprint.
- Bespoke stepover configurations
- Gowning SOP support
- Intelligent storage solutions
Cleancube Aseptic Pharmacies Annex 1 Material Transfer Compliance
Intelligent consideration must be given when reviewing the transfer path of all incoming materials and outgoing goods. Where possible, Guardtech will reduce the space required for material transfer to meet the bare minimum demands, allowing process space to be the dominant occupant. Transfer between classifications performs safely via H14 ventilated hatches.
- Bespoke transfer or trolley hatch configurations
- HEPA filtered active ventilation
- Electro-magnetic interlocks
- Grade 316 corner-less construction
- Double or triple stack hatches available
Cleancube Aseptic Pharmacies Pressure Regimes
A significant portion of aseptic pharmaceutical manufacturing relates to chemotherapy drugs. Balancing operator safety via containment against effective contamination control measures is the fundamental consideration for processing spaces. A mixture of positively and negatively pressurised rooms achieves the best outcome.
- Dedicated air supplies for individual processing suites
- Intelligent control systems for pressure balancing
- Highly accurate environmental monitoring systems
- Highly sealed rooms with air leakage rates incorporated into design
Aseptic Pharmacy Facilities Cleancube Aseptic Pharmacy Example Layout 1
Cleancubes come in all shapes and sizes – and every bespoke Aseptic Pharmacy facility is different. Click the button below to view an example layout in more detail to see how a large-scale Aseptic Pharmacy container module facility might take shape for your Trust.
Aseptic Pharmacy Facilities Cleancube Aseptic Pharmacy Example Layout 2
Thinking about Annex 1 and the process flow within your facility is critical. Click the button below to view an example Aseptic Pharmacy layout in more detail to see how the Cleancube team take shipping containers to create world-class Aseptic Pharmacy facilities.
Large-Scale Facilities Cleancube Multi
Whatever the scale of your ambition, the Guardtech Group have the solution – with Cleancube Multi you can create a new Aseptic Pharmacy suite of any size.
Not only can you place as many 20ft or 40ft modules as you need side by side, you can also stack them as high you require, linking the stories by staircases. The ultimate large-scale, pre-fabricated, off-site constructed cleanroom solution for the NHS and beyond.
