The text that follows is owned by the site above referred.
Here is only a small part of the article, for more please follow the link
By Tom Egan, vice president, Industry Services, PMMI, The Association for Packaging and Processing Technologies
Trends like novel therapeutics and limited space in manufacturing plants are leading many pharmaceutical manufacturers to transition to smaller batch production. The transition can involve trade offs between flexibility, production speed, and overall productivity. To make it work, pharmaceutical manufacturers should look to overall equipment effectiveness (OEE).
Calculating OEE involves examining availability, performance, and the quality of results, and it’s a critical measure of a machine’s productivity. While companies have sometimes used an OEE calculation with varying availability metrics, the best practices recommendation from multiple CPG teams comes from the OpX Leadership Network (founded by PMMI in 2011 as the Alliance for Innovation and Operational Excellence). The OEE calculator posted on the group’s website, OpXLeadershipNetwork.org, makes the calculation easy.
The latest equipment and services to help pharmaceutical manufacturers achieve maximum flexibility and OEE will be on display at Pharma EXPO 2015 (Las Vegas, September 28-30). PMMI, The Association for Packaging and Processing Technologies, has partnered with the International Society for Pharmaceutical Engineering (ISPE) to co-produce the show, co-located with PACK EXPO Las Vegas. The joint event will attract 30,000 attendees and feature 2,000 exhibitors showcasing technologies over 800,000 net square feet of exhibit space.
Get Good OEE
Ken Falk, product manager for the product inspection division of Mettler Toledo (Pharma EXPO Booth N-607) says 100 percent OEE is practically impossible. For example, even if all three factors were 95 percent, OEE would calculate to just under 86 percent.
“The worldwide average OEE rate in manufacturing plants is 60 percent, and a world-class OEE is considered to be 85 percent or better. Clearly, there is room for improvement,” he says.
As a member of the Organization for Machine Automation and Control (OMAC), Mettler Toledo also helped develop the PackML packaging machine language to enable consistent communication between all forms of packaging equipment and line controls.
Falk says Mettler Toledo’s product inspection technologies help improve OEE rates by reducing the number of false rejects with improved sensitivity for difficult products. They also help lower the frequency of performance validation routines and test time, and reduce changeover times. The company’s ProdX Inspect data management software, for example, is designed for seamless integration of product inspection devices to make processes more streamlined, accessible, and efficient.
Mettler Toledo will network its Pharma EXPO booth (N-607) and its PACK EXPO Las Vegas booth (C-1814) to demonstrate remote monitoring capability, PackML, and OEE functions.
Focusing On Changeover
Changeover times take center stage when it comes to OEE and flexibility. The increasing number of smaller batches many drug makers are producing require quick, accurate changeover, with no room for error.
PennTech Machinery Corporation (Booth N-549) is working to meet process flexibility demands from injectable products providers. The manufacturer of equipment for the pharmaceutical and biotech industries offers solutions for handling high-potency products in smaller batches to meet the needs of pharmaceutical companies and contract manufacturers. “There aren’t as many blockbuster products that require big runs,” says John Erdner, vice president, sales and marketing, PennTech. “It’s about frequency of runs, not speed. Production capacity has become increasingly dependent on running slow-speed lines efficiently and minimizing the downtime between batches. Now, it’s not about 600 vial-per-minute lines, it’s about 300 vial-per-minute, and even 100 vial-per-minute, lines.”
PennTech’s new external vial washer can run batches of 1,000 to 5,000 vials through the washing and drying process at speeds as slow as 100 vials per minute. The machine uses tool-less quick-release infeed and exit feed screws that help reduce changeover time between batches. A vial transfer belt seals the cap to block out moisture as the vials move through the high-pressure spray nozzles. The external vial washer is equipped with five servo drives to control vial movement and recipe-driven position adjustments. The servo monitors are also synchronized, eliminating the need for manual adjustments for consistency further reducing changeover time.
Small Meets Versatile
Smaller batch runs of multiple products demand greater versatility throughout the production line and everywhere in between — even in clean-in-place (CIP) equipment. Sani-Matic, Inc. (Booth N-508) will feature its ULTRAFLOW Portable CIP systems at Pharma EXPO. Self-contained, compact and portable, they work with a variety of single-use, re-circulated applications.
The ULTRAFLOW portable cleaning system features a small footprint and space-saving design, making it compatible with different pieces of machinery and easy to transport throughout the plant. The system can also clean very small processors, bioreactors, and fermenters, as well as centrifuges, media tanks, holding tanks, IBCs (intermediate bulk container), fillers, and storage tanks.
“A huge benefit of the ULTRAFLOW line is that it can operate with minimal draw on utilities. For example, it utilizes 23 percent less water than conventional CIP equipment,” says Chris McNulty, pharmaceutical and biotech sales manager of Sani-Matic, Inc.
The ULTRAFLOW system design allows for a high-turbulence flow rate and self-cleaning, eliminating the need for additional cleaning steps.
“We gain considerable savings as a result of treating fewer gallons of water with chemicals and managing less waste,” says McNulty.
Even When Automated, Seeing Is Believing
One of the most important steps in a manufacturing process is product inspection, and CapPlus Technologies (Booth N-828) will exhibit equipment that helps operators validate what they see.
“Most pharmaceutical and nutraceutical companies rely on visual inspection of finished oral dosage forms, and since this process depends largely on operator vision, it cannot be validated,” says John Rohrbough, the CapPlus director of sales and marketing. “The fully-automatic Insight 100, ‘validate-able’ inspection machine separates products which fall outside the acceptable limits and reports the nature and quantity of the defects.”
The information can be continuously used to find and fix problems that may exist within the manufacturing process.
Along the same lines, inspection machine provider Brevetti C.E.A. (Booth N-509) has a fully-customizable line that reduces false rejection rates by adding a “human” element to automatic visual inspections to reduce false rejection rates stemming from misidentifying a defect.
“The advancement came about as a process improvement,” says Susan Calabrese, USA sales manager, Brevetti C.E.A. “It mimics the human inspection capability by handling the container the same way a human would, examining it at different angles.”
Brevetti will demonstrate the A1 Human-like Inspection Machine at Pharma EXPO. Available as a four or six-axis robot, this machine can conduct particle inspection and re-check rejects from other semiautomatic lines at up to 50 containers a minute. Its software includes a new off-line setup mode that allows the parameters optimization phase to take place completely off-line.
With small batches and less floor space, pharmaceutical manufacturers need to know how to get the greatest value from their technology investments. These and other OEE and flexibility solutions will be found at Pharma EXPO and PACK EXPO Las Vegas 2015. For a more in-depth look, visit the Innovation Stage (Booth C-1049) session, “Why OEE as a Metric? Learn how to Design a System to Maximize Visibility into OEE” (Sept. 28, 1:00–1:30 p.m.). Learn more and register at PharmaExpo.com. Show admission is $30 through Sept. 14, when it increases to $100.