Gore PharmBIO Products
 Sanitary gasket maintains dimensional integrity


 Gore PharmBIO Products (Elkton, MD) offers its STA-PURE sanitary gasket for applications such as process steam, ultrapure water systems, media preparation, and upstream or downstream processing. The gasket is made of PTFE that has been processed for greater strength and dimensional stability. As a result, the gasket does not extrude into the bore of a piping system and reduces the likelihood of entrapment. The gasket also is designed to withstand 500 steam-in-place cycles without undergoing a change in its dimensional properties.

The expanded PTFE is of high purity and contains few extractables. Upon clients’ request, Gore can provide full lot traceability to the raw materials used to manufacture the gaskets. The gasket can be integrated into various systems, thereby enabling operations to be standardized. In addition, the gasket meets the American Society of Mechanical Engineers’s BioProcessing Equipment standard.

OYSTAR USA
 Cartoners move products safely


 The S series cartoners from OYSTAR USA (Fairfield, NJ) are designed for efficiency. Mechanical fingers incorporated into the units’ picking arms open cartons before they are placed directly into the carton chain. This positive-opening system is intended to prevent cartons from being improperly placed and obstructing the chain.

The cartoners include servo-driven technology that communicates with other machines in the packaging line. The servos and the handling system track the position of components to be cartoned and help improve product handling and efficiency. 

OYSTAR custom engineers infeed systems to fit clients’ applications. The company can provide infeed systems that load different components such as blister packs, inhalers, and product literature into a carton. The S series is designed to move components into the carton chain accurately, and the units require little maintenance.

Articles

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the September 2009 edition from Gore and Oystar.

September 2009 Editor's Picks: Products from Gore and OYSTAR

Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market. To find out more about small-format packaging machines, and about the kinds of companies that are taking advantage of them, 

 (EPR) spoke to Scott C. Garverick, vice-president of sales for Carton Service-Packaging Insights (Shelby, OH).

: 	Have pharmaceutical manufacturers embraced small-format machines for both in-house use and outsourced packaging? 
   
 

: 	Pharmaceutical companies and contract packagers are embracing small-format equipment, but small-format blister machines are more prevalent among contract packagers than among pharmaceutical companies. Smaller lot sizes are driving more companies to small formats to achieve smaller batches (which tie up less money in the supply chain), greater flexibility in the production of commercial product and samples, more inventory turns, and faster reaction time to shifting market demands.

:	What is the typical speed range for small-format versus large-format machines in cycles per minute?

:	Cycles per minute are not that much different between small- and large-format machines. Rather, it is the difference in the number of blister cards per cycle that is significant.

:	Wouldn’t a large format machine actually provide higher output in a shorter amount of time because it could produce two or more packs per cycle?

:	A large-format unit can yield two to three times as many cards per cycle as a small-format device. It’s the reduced tooling requirements, easier setup, and quicker changeover that make small-format equipment advantageous. 

:	If small-format machines require less tooling, does this mean that less metal and machining are needed for these precision parts, which are therefore less expensive? Or are the tools themselves more flexible (i.e., can the same tool be adjusted to produce different packages)? 

:	Small format means small tooling, less material to make tooling, fewer blister cavities to form, and less time to manufacture packages. Tooling is specific to a certain product or size and is not adjustable, but advantages are gained when standard blister sizes and perforations are used. 

:	Why would changeover be faster for small-format machines? 

:	Smaller tools are easier to handle, and changeover is simpler.

:	How much faster is changeover for small-format equipment than for large-format units? 

:	Changeover should be measured by the time it takes to produce a blister card that meets all quality requirements. With experience, an operator can change over the small-format machine in less than an hour, including tooling and print-mat installation, as well as production of the first blister card. 

:	What is the optimum run range for a small-format machine? 

:	Lot sizes of 100,000 cards and below are ideal for most small-format machines. Also, keep in mind that there is still a big difference between 5000 cards and 500,000. A typical contract packager would use several kinds of tooling and various blister lines for this wide range. The equipment used should be the right tool for the job. For example, will a blister card hold one tablet or 10? If it’s one tablet, a small-format machine would be inefficient for a batch of 500,000 units, but a small-format machine would be ideal for a run of 50,000 blister cards of 10 tablets each. 

:	Many large machines are highly automated, and cleaning regimens for small- and large-format machines would probably be similar. Because the cleaning team must ensure that no stray product from the previous run remains, aren't cleaning regimens basically the same, regardless of the size of the machine?

: Cleaning regimens are similar, but not the same, and there is a significant difference in magnitude due to size. Increasingly, pharmaceutical companies look for contract packagers with the ability to accommodate small-format blister packaging. Packagers who maintain small-format equipment offer those companies a significant cost savings, faster speed to market, and a competitive edge for their products.

Production Lines

Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market.

The Advantages of Small-Format Equipment: A Q&A with Scott C. Garverick

Steam is a valuable resource in pharmaceutical manufacturing facilities. Plant steam is important for process-heating applications, and clean or pure steam is often used for sterilization. A clean- or pure-steam system provides the correct quality and purity of steam at the required operating parameters on demand. Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.


Clean steam, which is needed for applications such as pharmacopoeia grade water for injection and pharmaceutical synthesis, is expensive to generate. It is created through a complicated, resource-intensive process. It follows that the costs of clean-steam system problems are high, and auditing a clean-steam system makes good economic sense. Periodically verifying that the system is run according to best practices helps to ensure optimal maintenance and uptime. This strategy also helps maintain the purity, quality, and thermal control of the clean steam. 

Clean-steam systems must conform to American and international good manufacturing practice, engineering guides, and other regulatory (e.g., US Food and Drug Administration and World Health Organization) guidances for water. A review of the system’s operation, installation, and performance can improve the system, ensure continued and reliable output, maintain regulatory compliance, and identify preventive-maintenance activities.

The audit process can improve the clean- or pure-steam system by including the following activities:

    Comparing blueprints with the site’s installation

    Verifying trapping locations and condensate removal

    Examining piping configurations such as dead legs, valve orientations, process-equipment interfaces, slopes, and drains

    Monitoring and investigating corrosion

    Assessing gasket and material selections

    Monitoring pressure-relief and safety systems

    Checking insulation and energy management

Failing to review or control the above items may decrease steam quality and, ultimately, system performance.


Malfunctioning or misapplied clean-steam traps affect energy consumption and process integrity. A steam trap that cycles too rapidly or has failed open can result in the following problems:

    High emissions from unnecessary combustion of boiler fuel to replace the heat energy lost through the trap

    Inefficient operation of the clean- or pure-steam generator

    Increased water-vapor emissions into plant environments.

A trap that is cycling too slowly or has failed closed results in the following problems:

    Backup of condensate, which is a high risk factor of not attaining specified process temperature and maintaining specified time-at-temperature for steam-in-place applications

    Water hammer, which is dangerous to plants and personnel

    Increased startup or sterilization times

    Increased production time and unit costs

    Reduced process performance and plant efficiency

    Increased production-system failures and reject rates.

Regularly scheduled trap surveys not only realize substantial savings, but also significantly improve process efficiency and reduce environmental concerns.


A steam-system audit should be tailored to an individual process or application. Auditors should begin by meeting with plant managers to explore strategies to improve performance and efficiency. After a preliminary discovery phase, auditors should determine and prioritize audit strategies, with the goals of reducing operational costs by managing steam systems according to best practices and resolving health and safety concerns. 

The audit process can include the plant’s steam-distribution loop or the clean-steam system. Audit teams often use an advanced steam-system assessment tool in the form of modeling software developed by the US Department of Energy and a private consortium. 

The steam-system audit report should highlight recommended actions and estimate the return on investment. The report should include an objective analysis to guide decisions about further actions. The audit report also should include the following items:

    Identification of poor engineering practices and advice on best practices

    Recommendations for reducing emissions and saving energy (e.g., by eliminating steam leaks, replacing misapplied or incorrectly sized equipment, repairing failed steam traps, recovering heat from the flash steam, installing or repairing insulation, and reducing fuel and make-up water consumption)

    Comparison of site emissions (e.g., of carbon dioxide, sulfur dioxide, and nitrous oxide) before and after the audit

    Identification of productivity improvements

    Identification of potential areas for improved product quality

    Planned preventive-maintenance schedule

    Photographic evidence of items such as misapplied trap types, incorrect and missing components.

Rouging is a common problem and is manifested by red, brown, or violet iron deposits on the heat-transfer surfaces of columns, vessels, and piping. An audit can uncover corrosion-prone areas, establish the extent of corrosion, and suggest remedial actions to reduce corrosion or reestablish a corrosion-free environment.

Proposed solutions to problems found during the audit should be based on conservative economic models. Solutions also should adhere to budgets, production schedules, and resource requirements. These proposals can include supplying and installing replacement parts, designing and implementing efficiency improvements, or a total overhaul of steam-system management. The result of a steam-system audit is a course of action that is economically sound and improves the operational, safety, and environmental aspects of a pharmaceutical manufacturing operation.

Dawn Cartwright Dukes is a product market manager for high-purity steam at Spirax Sarco, 1150 Northpoint Blvd., Blythewood SC 29016, tel. 803.714.2072, fax 803.714.2224, dcartwright@spirax.com.

In the Mixer

Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.

Equipment and Processing Report-09-16-2009

September 2009 Editor's Picks: Products from Gore and OYSTAR

The Advantages of Small-Format Equipment: A Q&A with Scott C. Garverick

The Economical and Process Benefits of Steam-System Audits