Validation Design

We at Helicon are specialists in the field of Controlled Environments (CE), we design, build and validate projects to client requirements based on your expectations and our experience, we advise on technical matters in relation to integration of a new facility or CE to an existing manufacturing facilities with a view to achieving a fully integrated and validated facility, so for us its key that we understand the end user requirements up front, so that we can design accordingly, design is not just M&E or Structural for us as a company, it’s the integration of them all the above with one key element end user element in mind at all times and that is validation. We believe that in creating a Controlled Environment that not only serves its purpose, we like to take it a step further and ensure that you the Client understand what we are designing for you to ensure the end product excels in many ways, such as running costs, control, lighting and cleaning. We as a company like to provide the personal touch, and build a relationship with our client. We focus all our efforts to ensure you understand design as for us this is key to you understanding your Controlled Environment.

Helicon design controlled environments for success and we consider every aspect of design to be critical to achieving an end user requirement that does not require continuous firefighting control measures.

 

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These are just a few aspects that we consider vital in the design stages of any Controlled Environment, we risk assess each aspect of the project based on your requirements.

We will sit with you the client and ask simple questions, such as, have you considered the following during the development of your CE URS.

⦁ Secure lockers for clothing and personal property
⦁ Shoe cleaner, with rotating brushes to remove gross contaminants Walk-off adhesive shoe mat
⦁ Air Shower, with HEPA filtered air jets to remove loose contaminants
⦁ Hand washing station, no-touch operation
⦁ Hand dryer (if not incorporated into washer), HEPA/ULPA-filtered air, no touch
⦁ Dispenser for glove liner or under glove
⦁ Glove washing/drying station (if gloves not clean) Headwear dispenser
⦁ Face mask dispenser
⦁ Waste receptacle—should be installed wherever packaging is removed
⦁ Garment Storage Facility—depends on garment type
⦁ Open Garment Rack for reusable garments
⦁ Enclosed Garment Cabinet for reusable garments (includes HEPA blower)
⦁ Garment Storage Shelves for packaged disposable garments

⦁ Waste Receptacle
⦁ Ergonomic Lean Rails support personnel while donning coveralls
⦁ Gowning Platform provides a noncontaminated surface to prevent violation of garment
⦁ Wiper dispenser—used to clean bench prior to putting on booties
⦁ Bootie/shoe cover dispenser (may also be incorporated into benches)
⦁ Waste Receptacle
⦁ Gowning benches, used when putting on booties. Booties stay on “clean” side
⦁ Cleanroom mirror for final self-inspection (side-by-side w/poster showing correctly garbed model)
⦁ Safety glass and over glove dispensers
⦁ Air shower—may be required in cleanroom entrance
⦁ Garment hamper for reusable garments to be laundered
⦁ Waste receptacle for disposable garments
⦁ Tools, supplies cabinet for overstock garments or cleanroom supplies
⦁ PAL/MAL requirements