Fresenius Medical Care
SOP Number: YES00032
Effective Date: 12/31/2024
Revision Date: 12/31/2024
Owner: Operations
Review Frequency: [Quarterly]
Responsibilities
List the roles and their responsibilities for this procedure. Be specific about who is responsible for each part of the process.
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Role 1: Recruiter
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Role 2: Account Manager
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Definitions
Provide definitions for any terms or acronyms used in this SOP that may not be commonly understood.
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Procedure Steps
YOUR EMPLOYMENT SOLUTIONS
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Fresenius Departments
Solutions/Saline Fillroom (5:00 start time)
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Responsible for maintaining a clean work environment, this department rotates between 3 different parts of the line. The beginning of the line is the printing station where you are printing labels on the bags, next is filling the bags with saline or solution – once filled, the bags go down the conveyer where they get an outer plastic packaging. The last zone is inspection - you will inspect the finished product for any particles, issues with the outer plastic bag, etc. The bags will then go to Packout.
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You rotate between the 3 zones, so you are not doing the same thing the whole 12 hours. The bags range in size from 2–6-liter bags.
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The dress code is in accordance with the SOP for this cleanroom. Dress from head to toe in a bunny suit. Hairnets, beard nets, shoe coverings, hood, and gloves are also included in the gowning.
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It is a chilly environment, around 60 degrees in the fill room.
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Fast-paced, good hand-eye coordination, patience, on their feet for long periods of time, rotate between stations.
Solutions/Saline Packout (5:00 start time)
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Responsible for maintaining a clean work environment, loading finished solution/saline bags on the cart (cart loading), pushing the cart to the sterilization tank, inspecting the bags once they are sterilized, packaging two bags at a time into boxes, and then palletizing those boxes once sealed.
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Once full, those carts do weigh about 1200-1300 lbs., however, they do run on a track system that helps alleviate that weight when pushing them to the sterilizers.
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The dress code is in accordance with the Fresenius dress code. No gowning is required. Steel-toed shoes are required.
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The environment fluctuates with the outside temperature.
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Team-work environment, very physical, on their feet for long periods of time, lots of heavy lifting, bending, pushing, lots of moving around, loud, can be slippery near the sterilization tanks.
Fibers (6:00 start time)
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Responsible for maintaining a clean and safe work environment, general understanding of Fiber winding and bundling process, cutting the wheels and then wrapping and cutting the bundles. Notify supervisors of any issues with the fiber production.
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The dress code is in accordance with the SOP for this cleanroom, which is in scrubs provided by Fresenius. They will be kept in a locker and are not to be worn outside of the plant. Hairnet, beard net, safety glasses and ear plugs are required.
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Between 60-70 degrees on the line.
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Fast-paced work environment, must be a good communicator, constantly moving, must be a team player, comfortable standing for long periods of time.
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There’s not a ton of heavy lifting, the fiber wheel weighs about 23lbs with the fiber strands on it. The height requirement for this department is 5’4” or taller due to overhead reaching to the vacuum.
Dialyzers (5:30 start time)
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Responsible for maintaining a clean work environment, open and position material for assembly line, load housing into the auto loader or manually add to belt, fill fiber bins for fiber insertion machine, manual insertion of fiber bundles, manual placement of blood port caps, label product eases, fill cases with dialyzers and product sheet, pallet stacking and wrapping, operate a pallet jack.
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Dress is in accordance with the SOP for this cleanroom. Steel toe, cleanroom shoes are required. Hairnet, beard net, ear plugs, safety glasses and gloves are required. They will also put a smock on over their clothes.
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Temperature ranges from 60-70 degrees.
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Must be comfortable standing for 12 hours, occasionally will lift/move up to 25 pounds, loud/noisy environment.
E-Beam (5:30 start time)
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Responsible for maintaining a clean work environment, transfer product from quarantine areas into processing areas, ensure production line is stocked, verify staged product matches product to be processed, label and move sterilized material to designated area, load and unload carriers with product and re-palletize.
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The dress code is in accordance with Fresenius dress code. No gowning is required.
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Relaxed, laidback environment. The temperature is between 60-70 degrees.
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Must be comfortable standing for 12 hours. Very physical, move 16 ton of product in one 12-hour shift, lots of heavy Lifting (lifting 5 dialyzer boxes at a time) and
moving.
Materials (5:00 start time)
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Responsible maintaining a clean work environment. Working safely, must be ok travelling between Fresenius at BDO and on 13th street. Move and handle material without damage, load and unload materials, move raw materials and finished goods in and out of quarantine control areas, pick deliver and verily transfer orders to departments.
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Dress is in accordance with Fresenius dress code: No gowning is required. Steel-toed shoes are required.
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Temperature varies with the outside temperature.
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Must be comfortable working 12-hour shifts, must be comfortable working at the
Fresenius in the BDO and on 13th street, must have at least 6 months forklift experience in the last two years, must be comfortable operating and learning how
to operate triple jack and stand up reach.
Rework (Mon- Thurs 6am-4:30pm)
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Fast-paced environment, constant moving, must be comfortable being on your feet for 12 hours. You will be working in the warehouse at Fresenius Medical Care and the BDO, must have reliable transportation to go back and forth.
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The dress code is in accordance with the Fresenius dress code. No gowning is required, but steel-toed shoes are required.
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You will be reworking all products (Dialyzers, PD saline, solutions, etc.) which include inspecting products for damage, repackaging product, unloading and re-palletizing, and disposing of product.
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Loud/noisy environment and temperature varies.
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This is the most physical department at Fresenius Medical Care.
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Guidelines and Best Practices {OPTIONAL}
Offer any additional guidelines, tips, or best practices to help with successful execution of this SOP.
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Approval and Revision History
|
Version |
Date |
Approved By |
Changes Made |
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1.0 |
12/31/2024 |
IT , ML |
Initial Creation |
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Contact Information
For questions or support related to this SOP, contact:
Role/Department: Operations
Email: [email protected]
Extension: 703

