Spit-And-Polish Clean
In 1996, when Vince Neville began working for the then two-year old Sepracor Canada Ltd., a pharmaceutical plant located in Windsor, N.S., there were only 40 pieces of equipment covered under the prev...
February 1, 2006 | By Carroll Mccormick
In 1996, when Vince Neville began working for the then two-year old Sepracor Canada Ltd., a pharmaceutical plant located in Windsor, N.S., there were only 40 pieces of equipment covered under the preventive maintenance program.
Today, 450 different pieces of equipment and tools in the 3,250 sq m plant, including 175 pieces of critical equipment, have files in the company’s Datastream MP2 computerized maintenance management system (CMMS). They range from small pressure gauges and calibration equipment, up to a nearly two-storey-high 3V Cogeim filter-dryer unit manufactured in Italy.
Sepracor, with its head office in Massachusetts, does pharmaceutical research and development and manufactures active pharmaceutical ingredients and a handful of drug products, including the asthma drug Xopenex and the sleep aid Lunesta. Most production is carried out in Windsor.
The Windsor plant, which is in the midst of an expansion — splitting space to make new milling and blending rooms with airlock chambers — keeps its three full-time engineering personnel running. Vince Neville is the technician responsible for the maintenance department, Rick Heagle is the associate director of maintenance and engineering and Marcel Falkenham is the project engineer, but is available to the maintenance department.
The workload, averaging 120 maintenance man-hours a week, is shared with chemical operators who work additional hours before or after their shifts on an overtime basis, and one full-time contractor. Several other contractors are brought in to do preventive and corrective maintenance, including specialized work like vibration analysis, meggering, thermoscans and battery maintenance. “We rely heavily on our contractors,” says Neville.
United States-registered drug companies are regulated by the U.S. Food and Drug Administration (FDA) with rules that apply to maintenance personnel and practices. For example, contractors’ credentials have to be on record for the FDA. They also must get Good Manufacturing Practices training before they wield any tools in the plant.
“This gives you a history of the pharmaceutical industry and what are the needs of the FDA,” says Neville. “For example, say you are hiring a contractor who has worked in a totally different environment than the pharmaceutical industry. You have to make him aware of the conditions he is working in, and the risk of cross-contamination. We tell them what we require, for example, that tools must be cleaned, and the gowning requirements for the production rooms. We make them aware of the special conditions here.
“Think of rust or grease that could show up in a product if it has been contaminated by a dirty tool, or by equipment that has not been cleaned after a repair has been done, especially if the piece of equipment has been opened up.”
This sounds strict, but barely begins to describe Sepracor’s attention to cleanliness. For example, production room walls get scrubbed down and the room is under a negative pressure so that if any chemical traces do get into the air, they cannot travel outside the room in which they are being used.
From a production point of view, the plant is most unusual. There is no product whizzing by, no noise beyond the whir of a centrifuge, and no vibration or smells. Production workers typically pad around in boot covers, masks, hairnets and gloves.
The production is mostly chemistry, hidden away in unusual equipment such as chemical reactors, centrifuges, hydrogenation reactors, vacuum chambers and filter-dryers. Most product travels through pipes and hoses between production stages. The final step is packing the bulk active pharmaceutical ingredients in drums and bags for shipping to other facilities for packaging.
The plant has a Monday to Friday, three-shift schedule, with a two-week summer shutdown, plus a 10-day Christmas shutdown, during which maintenance can be done if necessary. Equipment failures are rare.
Going back to the CMMS, Neville explains, “Because we are so regulated, our computer system has to be validated for the FDA, to demonstrate, for example, that our schedule doesn’t get disrupted. We use our MP2 system as a backup system to our paper trail. I use the CMMS to generate PMRs, but I have to compare them to paper copies of our scheduled events.”
Each PMR (preventive maintenance report) in MP2 is linked to a scanned PDF document file of the signed PMR, which contains the procedure to be followed, and is linked to a Microsoft Word document of the PMR. Any change to a PMR must be signed off by both the Engineering and Quality Assurance department heads. All of the completed engineering work orders are also entered into the MP2 system.
Sepracor has a $700,000 spare parts inventory and spends about $100,000 a year on spares. They are all recorded in the MP2 software and each is linked to its vendor and to substitute suppliers. “We try to have spares for everything here that is critical to production, such as all of the motors,” Neville says.
Neville’s team has been working to make maintenance operations more efficient and effective by, for example, standardizing equipment such as the Busch vacuum pumps. He explains: “We are gradually standardizing as much equipment as possible. We have also piped vacuum pumps together, so if one fails we can open a valve to the other vacuum pump as a backup. We also have a spare vacuum pump in a box. We are always trying to improve our systems to keep them both operator- and maintenance-friendly.
“We try to standardize on the mechanical equipment that attaches to the chemical reactors, depending on the equipment size and requirements. We are also standardizing our remote temperature devices for purposes of calibration and replacement by using quick-plug connectors.”
Because much of the equipment and maintenance tools are very specialized, training is important, both for the contractors and Neville. To name just two of many courses under his belt, he has been to Texas for a Flowserve Corp. pumps and mechanical seals course, and last year he went to Rochester, N.Y. to a Pfaudler plant, which manufactures glass-lined steel equipment for the pharmaceutical industry; Neville relies heavily on the manufacturers — some of which are in Europe — and suppliers for OEM parts.
With two machine shops just down the street, Sepracor has no need for heavy machining equipment, but it is well-supplied with field tools — and some unusual ones at that, such as a 5,000-volt spark tester for testing the integrity of the glass lining in the reactor vessels.
Maintenance also uses pressure-testing equipment, since seal and pressure vessel integrity is critical to maintaining inert atmospheres in the vessels and perfectly controlled environments throughout the production process.
Another special piece of maintenance gear is a kit for making Teflon-lined pipe, for which contract maintenance workers receive special training. “We brought in a trainer and had a number of our contractors certified in the process of assembling and fabricating Teflon pipe. There are now trained pipefitters who are using this special tool for fabricating Teflon line pipe required for new equipment installations and for equipment repairs,” Neville explains.
One of Sepracor’s biggest challenges, and one which draws on the expertise of the maintenance team, arises when the company takes processes from the lab and scales them up. “We have to source or fabricate accessories for the equipment to meet production-size batch requirements and fabricate the conduits and piping that the operators require in order to make additions to vessels, similar to what was done in the lab,” explains Neville.
Another challenge is sourcing components that do not react with the product or raw materials such as Teflon, titanium, Hastelloy (a ‘super alloy’) and glass that can withstand the production environment. Neville refers to chemistry compatibility charts for each chemical as an aid to materials selection.
“I like the variety of
equipment that you just don’t get to see in regular industry,” Neville says. “There is so much equipment and many theories behind their operation. It is rare that I do the same thing twice.”
Montreal-based Carroll McCormick is a senior contributing editor for Machinery & Equipment MRO.