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ProSys Technology specialize in the design, manufacture and validation of Aseptic Isolators and RABS systems to meet the ever-changing requirements of the Pharmaceutical and Biopharmaceutical industries.
When specifying a containment Isolator, there are some important aspects to consider. To prepare a URS, the following information is necessary to the Isolator supplier to ensure the proposed design meets all of your processing needs.
| Product Occupational Exposure Limit | Integrated Equipment |
| Process description | Special Internal Environment (RH, O2) |
| Incoming Materials | Electrical Hazard Rating |
| Exiting Materials | Available space with ceiling height |
| Waste Removal | Limiting doorway dimensions |
| Cleaning method and solutions | Sketch |
PRODUCT OEL
Often a URS will indicate an Occupational Exposure Band of the product being manipulated within the Isolator. An OEB Band 4 has an OEL (Occupational Exposure Limit) of 1 – 10 micrograms per cubic meter. The design of the Isolator will be different for a 1 microgram/cubic meter OEL versus 10. The actual worst possibility Occupational Exposure Limit of the product should be included in the URS.
PROCESS DESCRIPTION
At ProSys, we want to understand your entire process. Not just what is happening inside the Isolator but also, what’s coming in? What’s going out? Where does the exiting product go next? Our preferences is to meet with you to gain this understanding. We make design recommendations based on our 25 years of past expertise in Isolator design/manufacturing experiences.
INCOMING MATERIALS
Not all 5 Liter containers have the same dimensions. Various aspects contribute to the difference in dimensions, I.E. bags are more difficult to predict their actual dimensions and an Isolator’s door design and size selection depends on the actual dimensions of the incoming material container. Quantities of each help determine the chamber size and if shelving is required. A list of other tools and supplies with sizes and quantities should also be provided.
EXITING MATERIALS
What is the final package size and quantities?
Like incoming materials, what are the actual dimensions of the exiting container(s). This helps with door sizes between chambers and exit door size and its removal method.
WASTE REMOVAL
What waste does your process generate? Are there used containers, bags, tools, etc. that need to be removed? As before, quantities and physical dimensions of each help determine the door size and its removal method.
CLEANING METHOD AND SOLUTIONS
Isolators can be cleaned manually by wipe down, by spray wands and by CIP spray balls. Manual wipe down requires a very small Isolator chamber size so that every surface can be reached. The most common cleaning method is using a spray wand. Cleaning solutions can affect elastomer and glove material choice. Cleaning solution types should be part of the URS. Chamber floor drains are typically tri-clamp connections but can include diaphragm valves if required.
INTEGRATED EQUIPMENT
Integrated equipment ranges from weigh scales to mills to lyophilizers. The more complex the equipment, the more input should be solicited from the Isolator supplier. ProSys prefers to help early in the project to avoid integration pitfalls. As a minimum, a URS should include the make and model numbers of integrated process equipment. Data sheets and dimensional drawings are a huge help.
SPECIAL INTERNAL ENVIRONMENT
When solvents are present in the Isolator room or inside the Isolator during the process, a hazardous classification should be provided. This includes Class, Division and Groups of the solvent vapor or combustible dusts being generated. This impacts the cost of the Isolator, especially if the exterior of the Isolator needs to be rated.
Seismically rating the Isolator would also significantly impact the Isolator’s pricing and design.
AVAILABLE SPACE
Often, Isolators are to be installed in an existing room. It is important to note how much space will be available for the Isolator and if the Isolator will go up against a wall. Ceiling height must be provided. This helps, not only with the sizing of the Isolator, but also the location of utility panels, bag out ports and RTP’s.
LIMITING DOORWAYS
Limiting doorway height and width are crucial. If the receiving area is a substantial distance from the room, and the path between the two has multiple doorways and hallways of different sizes and many corners to navigate, the Isolator design will be impacted. What is the elevator door size and internal L x W x H? Does the Isolator need to go in a room on the second floor or higher? These are just a few things that must be considered before the design process.
Although this may come as a surprise, room drawings and integrated equipment drawings, or even a simple hand sketch included in the URS helps us gain a strengthened understanding of your requirements.
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At ProSys, our Technical Sales Managers have many years of experience, with a strong background in the Pharmaceutical and Biopharmaceutical industries. We recommend working with our customers from the very beginning of spec development to assist in preparing the Isolator requirements.
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