How to Ramp Up Medical-Grade Plastics Production for Increased Demand

How to ramp up medical-grade plastics production for increased demand.
General

How to Ramp Up Medical-Grade Plastics Production for Increased Demand

Coping with the sudden pandemic threat of COVID-19 has turned much of the business world on its head, causing enormous changes in economic activity and product demand.

At Conair, changes have rippled through our operations as well. Some customers are coping with production slowdowns, while others are rapidly adapting or expanding their operations to meet a surge in new production demand.

We’re working with customers to respond to COVID-19 related production needs in four main areas:

  • Medical-grade tubing, hoses and molded connectors for respirator production:
    Since March, North American processors have ramped up production capacity to serve respirator manufacturers who are dramatically increasing output to meet skyrocketing U.S. and global demand.
  • Containers and packaging for COVID-19 test kits:
    After the U.S. Food and Drug Administration granted Emergency Use Authorizations for COVID-19 test kits to more than 16 different companies, processors have been racing to produce test kit components including fluid containers and packages to meet demand for hundreds of thousands of tests per week.
  • Films, fabrics, and molded components for personal protective equipment (PPE), especially face shields and masks:
    Driven by the need for respiratory protective equipment, experts at Grand View Research project that the PPE market will grow at a compound annual rate of 8.5% through 2027.
  • Single-use, disposable packaging for beverage, food, and other products:
    With the increased focus on hygiene and longer shelf life for produce, many fast food and retail chains, as well as several governments, have rolled back policies aimed at disposable plastics, resulting in a strain on supply chains.

Manufacturing PPE

Meeting the Hurdles to Medical-Grade Production

Many therapeutic and testing products and components associated with COVID-19 treatment, including items in the first two categories above, require production in at least an ISO 8 or Class 100,000 cleanroom.

Other medical components, including syringes, drug delivery products, and sterile or implantable products, require production in ISO 7 (Class 10,000) cleanrooms, where standards are even more stringent.

Of course, to launch or expand medical production operations in a cleanroom environment, processors have to surmount several hurdles:

  1. Meet ISO medical production quality requirements, including:
    • ISO 9001—Quality Improvement Processes
    • ISO 13485—Quality Management for Medical Production
    • ISO 14644—Cleanroom Requirements (Similar to US Standard 209E)
    • ISO 17025—Equipment Calibration Standards
  2. Meet U.S. Food and Drug Administration 21CFR requirements that detail CGMP (current good manufacturing practices) for medical devices and pharmaceutical packaging.
  3. Create additional cleanroom production space. Therapeutic and testing devices associated with COVID-19 treatment generally require production in a minimum of ISO 8 or Class 100,000 cleanrooms, according to standards that govern air turnover and limit generation of particulates, chemical vapors, and airborne microbes by equipment and personnel.
  4. Select, install, and certify cleanroom production equipment. Initiating medical production requires that all production equipment and auxiliaries achieve documented compliance in terms of features, calibration levels, and documentation requirements.

Cleanroom plastic processor

Addressing Medical-Grade Plastics Processing Requirements

With time of the essence, medical-grade component manufacturers are looking for:

  1. Production and auxiliary equipment designed and ready for cleanroom use.
  2. Included documentation and features that expedite both equipment installation and the regulatory compliance steps required to initiate medical product production.

In situations like this, a customer typically comes to a supplier like Conair and describes the tube or hose requirements (ID, OD, number of lumens) together with the resin type and production rates required.  From that, we calculate throughput and pounds per hour and consider how to size up the equipment to get it done. To hit those numbers, we need to blend at a certain rate, dry at a rate, and feed extruders at a certain rate.  Then downstream, we’re looking at sizing and cooling tanks, pullers or puller/cutters, and coiling equipment, all sized to meet the product requirements.

Of course, if the customer is producing medical grade products, the FDA requires that production equipment be constructed of compliant materials.  For an ISO 8 cleanroom, the focus is on minimizing particulate generation, chemical vapors, and airborne microbes.  Compliant equipment is usually made with contact surfaces of anodized aluminum or stainless steel, or certain acceptable powder coatings, as well as chemical-resistant HMI surfaces (to allow antiseptic wipe-down) and special urethane wheels that don’t generate particulate the way that vinyl or rubber wheels can. Even the belts used on extrusion pullers are made of a special, particulate-free material.

Requirements for ISO 7 cleanrooms are much tighter to allow for production of components used in sterile devices, syringes, vials and implantable devices, and pharmaceutical packages.  In these settings, compliant equipment and auxiliaries utilize stainless steel housings, castings, and covers; FDA-compliant gasket materials; plenum-rated cabling; and water cooling systems to eliminate the use of cooling fans.

Accelerating Delivery Times for Medical-Grade Production Lines

Meeting medical-grade requirements like those above quickly is where Conair MedLine® auxiliaries come in. They have been designed to be ready to go into cleanrooms. They’re built with compliant materials and features based on the cleanliness level required.  Because medical manufacturing lines require validation, we pre-calibrate MedLine equipment at the factory and provide certifying documents to validate their performance. And, we provide additional support and documentation needed to expedite the installation, compliance, and certification steps required to initiate medical-grade production quickly.

Medical-grade plastics production cleanroom

Conair manufactures its MedLine auxiliaries in North America and has been prioritizing COVID-19 related medical orders to keep them rolling. To expedite essential orders to medical customers facing COVID-related production needs, our sales, manufacturing, and vendor teams regularly convene and review the entire production chain – orders, inventories, critical lead-time components, build status, critical vs. non-essential orders…everything.  By establishing priorities up front, we have been able to save medical customers affected by the COVID-19 crisis weeks in delivery times.

For example, a customer with a new extrusion line order scheduled to ship in July asked for help.  Demand for IV tubing (PVC) had exhausted their capacity in March and their medical customers needed more IV tube as soon as possible. They asked Conair, “What can you do to help?” By utilizing MedLine products and prioritizing their order (with understanding and permission from other customers), Conair delivered their new medical extrusion line in mid-May – 10 weeks ahead of schedule.

In another case, a medical customer found they couldn’t keep pace with soaring IV tubing demand, despite implementing 24/7 production early in 2020.  They began calling suppliers in late March, essentially asking the impossible: “Can you get us an extrusion line in eight weeks?” which is less than half the usual timeframe.  We didn’t have all of the needed equipment in our production chain, but when word of the request got around, the team at the Conair Extrusion Technical Center stepped up. With customer trials at the center on hold due to travel restrictions, they volunteered the center’s MedLine extrusion equipment at the center:  a multi-pass cooling tank, an ATC tube coiler, and a conveying system.  Together with a factory-built Medline puller-cutter and an expedited delivery from our measurement systems supplier, Conair delivered the order last week, meeting the customer’s “impossible” eight week timeframe.

Simplifying setup of clean processing facilities white paper

Comments