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Press Clipping / Mar 19, 2020

Stepping up to the hand sanitizer shortage

Chemical companies, breweries, and perfumeries take to making and donating a vital commodity in short supply

Production of Hand Sanitizers | Hovione

About 6 weeks ago, the pharmaceutical chemical maker Hovione ran out of disinfectant gel at its plant in Macau. “So the guys just used their heads and started manufacturing it themselves,” CEO Guy Villax says.

Hovione is one of a number of chemical, distilling, and other companies that are starting or increasing production of hand sanitizers and sanitizer ingredients needed during the coronavirus pandemic. Some are already in the sanitizer business. Others, like Hovione, jumped in during a time of need.

Impressed by the initiative in Macau, Villax put staff at the company’s plant in Loures, Portugal, to work making alcohol-based sanitizer at metric-ton scale. Hovione is distributing it to hospitals, other health-care facilities, and municipalities in solution and gel formulations.

Hovione has enlisted a dedicated production line in Loures staffed by a team of about 30 workers. The company is using a formula available from the World Health Organization involving mainly ethanol or isopropyl alcohol and glycerin. Production volume was expected to reach 5 metric tons (t) during the week of March 16 and as much as 30 t by the following week.

“At the moment we have hospitals asking us for 6 to 10 t, small entities asking for 100 L,” says Filipe Neves, pilot plant operations director, who is overseeing the project for Hovione in Loures.

In Germany, the big chemical maker BASF says it is preparing to manufacture hand sanitizer at its headquarters complex in Ludwigshafen, where it makes raw materials for sanitizers. The company plans to distribute the product to area hospitals.

UK-based Psychopomp & Circumstance Distillery, which normally distills gins and rums, is using its still to make sanitizing hand gel that it is giving away. Consumers can top up their own refillable bottles at the firm’s still in Bristol and leave a donation for a local children’s hospital.

At the moment we have hospitals asking us for 6 to 10 t small entities asking 100 L.

Filipe Neves, pilot plant operations director, Hovione

The company started out mixing its alcohol with aloe vera gel but has since switched to glycerin. “We are making as much of it as we can without going bankrupt,” Psychopomp cofounder Liam Hirt says.

Ireland-based Listoke Distillery has also switched production from gins to alcohol for hand gels, as have Taiwan Tobacco and Liquor and a number of small US distillers.

The flavor and fragrance producer Firmenich has shifted production at its La Plaine, Switzerland, facility to disinfectant solution. LVMH, the parent company of luxury goods maker Luis Vuitton, has switched three of its perfume facilities in France to making “substantial quantities” of alcohol-based hand sanitizer. The firm is giving the product to the French health authorities for free.

Specialty chemical manufacturers in the business of making sanitizing and disinfecting chemicals are boosting production. Lanxess is significantly increasing output of its Vikron sanitizer in Sudbury, England—introducing a second shift. The company recently donated a metric ton of disinfectant to hospitals in Wuhan, China, the epicenter of the virus outbreak, and to nearby cities.

And Gelest has significantly ramped up production of its Biosafe antimicrobial agent at its facility in Morrisville, Pennsylvania. Based on a silane quaternary ammonium salts, Biosafe punctures the cell membranes of microbes, destroying them on contact. Applications include formulations used by food service workers.

Biosafe is also the microbe-killing ingredient in a laundry additive called Certainty Smartboost, from the uniform company Careismatic Brands, which is sold primarily to health-care workers in specialty stores near hospitals. Workers use the treatment on their hospital scrubs or uniforms because it provides antimicrobial protection after they are washed.

Drums of Biosafe are “flying off the shelves” to formulators of cleaning products, including nonwoven wipes, according to Gelest CEO Ken Gayer. “We’re now also seeing direct orders from hospitals that want cases and cases of this material and are giving it to staff members.”

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Key Takeaways Multiple departments, including engineering and quality assurance, are responsible for evaluating GMP equipment and facilities. Regulatory inspectors require well-organized, preferably digital, maintenance documentation during GMP audits. A computerized maintenance management system (CMMS) is crucial for tracking maintenance activities and ensuring high performance. Common mistakes include neglecting criticality assessments, relying solely on time-based maintenance, and failing to consider maintainability during design. Adequate commissioning time is crucial for equipment lifespan and maintenance reliability. Construction and maintenance of manufacturing buildings and equipment fall under good manufacturing practices (GMPs) regulations (1–5). Pharmaceutical manufacturers can comply with these rules in the form of risk-based maintenance programs. Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance. PharmTech: Which department is responsible for evaluating GMP equipment and facilities? Basile (Hovione): The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance. Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency? Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience. Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance. What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities? Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly. Another mistake might be failing to consider design for maintainability during upgrades and not during the design phase. Adequate space and access to equipment, standardized tools, having the right pickups on equipment for condition-based maintenance [are important considerations]. I can't tell you how many times I've seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it. Failing to consider design for maintainability and not bringing maintenance in during the design phase is one mistake that people often make. Not carving out a role for a dedicated maintenance planner is also a misstep. At Hovione, we have a dedicated reliability engineer and maintenance planner that help in the evaluation. This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution. These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands on experience. In fact, the best planners are usually seasoned mechanics. One final failure we see often is not building in enough time for commissioning. The lifespan of equipment can be greatly influenced during the commissioning phase. This is where maintenance reliability starts. Too often, commissioning is rushed through, and equipment and preventive maintenance plans and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis. 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