Case Studies
NEEDLE SHEATH REMOVER
Handling thousands of needles a week when supplementing multi- chamber parenteral nutrition (PN) bags and compounded PN bags, needle stick injuries were an ever present risk to the Production Operator.
The process requirements meant that the use of safe needles was not possible or practical when preparing thousands of bags per month.
After reviewing the process steps required and discussing with the Production Operators when needle stick injuries occurred the design team firstly looked for an available needle sheath remover which could hold the needle sheath until the point of re-sheathing.
The limited commercial options available were discounted due to inaccessibility to clean and disinfect the devices simply. As no viable option was available the design team designed their own. The simple and cheap device produced incorporated the following design features:
- made from stainless steel 316 and finished to the same specification as the horizontal laminar flow booth working surface
- ease of cleaning and disinfection and compatible with typical disinfectants
- suitable for disinfection in hydrogen peroxide gassed isolators
- an ergonomic design for both left and right handed use
- protection of fingers when removing and replacing the sheath
- an upright holder of the sheath enabling ease of re-sheathing
- a robust design allowing air flow through when left in a Grade A critical zone
The end result was an immediate hit with the Production Operators not only making it safer when handling needles but also improving efficiency by the ease of re-sheathing
HLAF
Preparing several thousand Parenteral Nutrition (PN) bags per month at their aseptic unit in Sheffield, B. Braun required a horizontal laminar flow booth specifically designed to allow the Production Operator to work compliantly and with ease.
Reflecting on the compounding process and the operational challenges encountered working from standard sized cabinets the design team, working with Envair, designed, installed and qualified eight bespoke cabinets. Specific design improvements included:
- a protected HEPA filter incorporating a stainless steel perforated diffuser in front of the filter
- a silicone seal free HEPA filter capable of being tested and if necessary replaced on the same day reducing production down time
- additional depth and breadth of the working surface, ensuring that the compounding process could be fully enclosed within the Grade A critical working zone with ease
- a continuous particle monitoring head located adjacent to the PN bag filling and connection port ensuring particle monitoring was reflective of the highest risk location of the process
- an upgraded HDMI panel clearly visible to the operator with audible alarms and set points for filter pressure differentials, air flow velocity parameters and historical alarm conditions
- the installation of UVC germicidal lamps which would illuminate automatically and safely out of hours to assist in the disinfection of the Grade A critical zone and equipment
Working in conjunction with the clean room design team the cabinets were installed fully assembled and can be removed and re-introduced via an adjoining Grade B air lock to enable major engineering work to them without affecting the qualification of the production cleanroom and also minimising down time.
PACKING SOLUTION
Producing over several thousand supplemented multi chamber Parenteral Nutrition bags per month the aseptic unit of B. Braun at Sheffield required a packaging solution for the aseptically produced finished product that would protect it during transit. Additionally in order to provide the validated shelf life of the aseptic product it was essential that the product could be chilled to between a constant 2-8°C whilst in transit.
Taking the design requirements further the design team set additional requirements of the packing solution including:
- enable the immediate shipment of product without lengthy pre-chilling thus reducing time to dispatch from 30 hours to less than 4 hours
- avoid the use of packing that would cause disruption when the customer opened it i.e. polystyrene chips and vermiculite
- light weight and compact to store before assembly
- robust to allow for stacked storage on pallets without collapsing
- recyclable with ease by the end user
- ensure contents up to 12.5L of solution would be chilled in transit at a rate at least comparable to an on-site cold room
- would protect the delicate product from typical logistic challenges including drops
- cheap to allow for emergency shipments without the need for expensive same day chilled couriers
All of the above criteria were achieved resulting in a validated product specific packing solution that not only protected the product in transit but reduced emergency shipping costs by up to 90%, savings that were directly passed to the customer.
NOVEL COLD ROOM DESIGN
Preparing thousands of Parenteral Nutrition bags per month the Aseptic Unit at B. Braun Sheffield needed to reduce the repeated manual handling of these bags, weighing up to 5Kg each, whilst improving the time taken from point of manufacturing to refrigeration. The new extension build team reviewed the current process and proposed a new one.
To enable this new process a Grade D cold store was developed that would act as an air lock between the Grade D inspection area and the outer unclassified area. Working with Bassaire, the cleanroom extension contractor, the specialised refrigerated cleanroom was designed, built and qualified. Utilising PTFE HEPA filters to provide the required air quality, the cold store also maintains a pressure differential between the Grade D and unclassified areas and a constant temperature throughout between 3-7°C. Dual entry is controlled with a traffic light system ensuring the two personnel entry doors are not opened simultaneously. A dual condenser system is installed to provide resilience of operation. Full IQ/OQ and PQ was performed jointly by Bassaire and B. Braun.
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