Part Two – Container Integrity Testing – Vacuum Decay and HVLD | Whitehouse Laboratories

 

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Part Two – Container Integrity Testing – Vacuum Decay and HVLD | Whitehouse Laboratories

Author: Brian Mulhall – Managing Partner, Director of Container Testing

In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.

Vacuum Decay

Vacuum Decay leak testing is based upon ASTM F 2338-09 “Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method”. This nondestructive test facilitates the identification of package leaks that may not be visibly detectable. It operates on the principal of vacuum decay. A test package is placed into a chamber that is subsequently exposed to vacuum. Sensitive pressure transducers monitor changes in chamber pressure; a result of package headspace being drawn through any leaks present. Using acceptance criteria established through method development, quantitative test results are qualitatively judged as pass or fail.

This type of testing is applicable to any package containing headspace, including, but not limited to, parenteral vial packages, screw-capped bottles, auto-injectors, and flexible bags or pouches. Vacuum decay is generally not recommended for liquid filled packages, as proteinaceous product has the potential to clog and mask leaks. However, if vacuum decay is the preferred method, alterations can be made to the method development and validation process to accommodate liquid filled packages.

Electrical Conductivity (HVLD)

The electrical conductivity leak test, also called high voltage leak detection (HVLD), or “the spark test”, is an approach for detecting leak presence and potentially the location of a leak(s) in the wall of a nonporous package, rigid or flexible, containing liquid product. The principle of leak detection is based on quantitative electrical conductance measurements. The presence of a leak path in the proximity of electrically conductive liquid results in a drop in test sample electrical resistance, as evidenced by a spike in current above a predetermined pass/fail limit. This highly sensitive method even works to detect package defects clogged by product formulation proteins or salts. Stability studies by clients have supported the use of this technology for nondestructive leak testing a variety of product formulation types. This should be considered, however, on a product-by-product basis.

Package systems that may be tested by HVLD include parenteral vials, pre-filled cartridges and syringes, plastic containers, and plastic bags or pouches.

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Part One – Current State of Container Integrity Testing | Whitehouse Laboratories

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Part One – Current State of Container Integrity Testing | Whitehouse Laboratories

Author: Brian Mulhall – Managing Partner, Director of Container Testing

This series of articles will review the state of Container Closure Integrity Testing (CCIT) today and the various methods currently available, the factors for choosing the most optimal method and current regulatory guidelines under development.

Dye and microbial ingress testing have long been employed for assessing the integrity of container closure systems. However, research and experience as shown such tests are limited in their ability to provide accurate, sensitive and reliable data for definitive container closure integrity verification, especially for packages that demand the highest degree of product protection.

With the advent of new technologies, various sensitive and data-producing test methods have been developed to bring package integrity testing into the 21st century. The development of these new and improved methods over the past 10 years has led to regulatory agencies taking a fresh look at how to best guide industry. Within the next few months the United States Pharmacopeia will publish new General Chapter 1207 that deals specifically with container integrity and will outline in detail the various methods that industry can use. These new and improved Container Closure Integrity Tests have been successfully used to

  • characterize packages and materials,
  • optimize sealing parameters,
  • evaluate package storage temperature impact,
  • replace sterility tests for product stability batches,
  • screen production lots for faulty packages, and
  • support regulatory submission applications for product commercialization around the world.

The new USP 1207 chapter will prove to be a useful guide for companies that are in need of CCI testing. As this area of qualification is often misunderstood, the initial draft of the general chapter has taken a basic approach and will dedicate a section to each of the methods that may be employed. In addition, the chapter will discuss all the factors that must be considered when choosing the most optimal method. Key factors test method selection include package type, chemical make-up of product, type of seal and storage conditions.

With so many variables under consideration, there will not be one method that will satisfy all the CCIT needs of a company. Over time, the industry will need to have the ability to employ all the various methods if they are to insure that their products and package systems meet the stringent GMP regulatory requirements.

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Continue Learning Beyond the INTERPHEX Show Floor

INTERPHEX Free Spring Webinar SeriesJoin us for our complimentary spring webinars from the convenience of your own desk.

Schedule of upcoming webinars:

  • Single Pass Tangential Flow Filtration for Bioprocessing May 21, 2014 at 2:00pm EST Presented by EMD Millipore This webinar reviews the advantages of single pass tangential flow filtration (SPTFF), discusses applications where SPTFF adds value, provides recommendations for process development, and presents guidance for scale up and implementation. Find out more and register>>
  • Performance and Economics Analysis of Fully Automated Single-use Tangential Flow Filtration Process June 5, 2014 at 11:00am EST Presented by Pall Life Sciences Fully automated single-use tangential flow filtration (SUTFF) system, coupled with the Cadence™ single-use TFF modules brings real-time process control, monitoring, flexibility and reliability in manufacture.  The Webinar presents Pall Life Sciences’ design approach for SUTFF and the process economics analysis to show significant utilities, cost, and time savings as it compares to conventional re-use TFF. Find out more and register>>
  • Taking Life Sciences to the Cloud June 12, 2014 at 2:00pm EST Presented by Cornerstone OnDemand Life science organizations face unprecedented compliance and transparency expectations today.  In order to meet requirements, focusing on the development of your people has to be just as important as your improving upon your product. In this webinar, learn how the cloud can address compliance requirements, empower your employees and improve performance.Find out more and register>>
    INTERPHEX Webinar Series
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Day Two of INTERPHEX Recap

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Day Two Wrap up at INTERPHEX 2014, sponsored by PDA
– Positive Reactions at Leading Pharmaceutical & Biopharmaceutical Manufacturing Event -

NEW YORK CITY, NY, March 19, 2014 – INTERPHEX (International Pharmaceutical Expo) the leading annual trade event dedicated to the pharmaceutical and biopharmaceutical manufacturing industry is being held this week at the Jacob K. Javits Center in New York City, NY.
This year, INTERPHEX along with premier sponsor PDA (Parenteral Drug Association) has brought together over 12,000 industry professionals and more than 650 exhibitors to learn, network and source from the latest technology, equipment, education and services. And after two days of the three-day show, companies are impressed with the quality and value of this year’s attendees and look forward to seeing what the final day will bring.
“I have nothing but good things to say about INTERPHEX,” said Suzy Arraste, Marketing Manager at Cozzoli Machine Company. “We come to the show because half of our company is in the pharmaceutical industry and this is a great way to get leads.”
IPS Technologies Floor Tours
A highlight of the day was the five Technologies Tours led by IPS-Integrated Project Services. Attendees on the Biomanufacturing tour met with top industry vendors, including EMD Millipore, GE Healthcare, Parker-Hannifin Corp., Pall Life Sciences, Thermo Fisher Scientific, and ASI Life Sciences who gave brief presentations showcasing their new manufacturing technologies, novel applications and equipment innovation.

“I couldn’t be more pleased with the titles and positions that IPS is bringing to us on the technologies tours,” said Amber Sherrick, Marketing Manager at ASI. “INTERPHEX is always a great way to premiere new products while getting to know customers and networking.”

Other Technologies Tours included: Advanced Aseptic, Inspection and Packaging, Modular Construction, and Oral Solid Dosage.

Featured events
The INTERPHEX Connects Innovation Stages also brought together crowds of industry professionals for complimentary, enriching presentations. Topics today covered continuous bioprocessing and manufacturing for biologic drugs, as well as a special forum presentation on Changing Contract Services sponsored by Pharmaceutical Technology and BioPharm International. Jim Miller, President of PharmSource spoke to a packed audience about the consolidation of the CMO universe and the evolution of new services combinations to fit the changing R&D requirements of bio/pharma companies. In addition, Miller offered an industry outlook for the next few years.

Featured presentations at the first ever PDA Education Sessions @INTERPHEX included Parenteral Packaging and Supply Chain for the 21st century.

On the show floor
It was nothing but positive news on the show floor as well. GE Healthcare Marketing Manager, Jiyoung Lee said, “We go to INTERPHEX every year and it’s always great; we are constantly generating leads.” The company took a unique approach to their booth this year, focusing on the four pillars of bioprocessing: upstream, downstream, single-use, and services.

A spokesperson from GEA Process Engineering also agreed that the show is a great way to network and get leads for potential customers for products like their MODUL Tablet Press, designed to process high-potency products.

Thermo Fisher Scientific – who has been exhibiting at the show for more than ten years in order to show the scale of their company’s capabilities – mentioned they have been getting tons of booth traffic. They also said they are pleased with the sponsorship opportunities that INTERPHEX offers them; they will be sponsoring the St. Patrick’s + 2 Industry Celebration tonight.

Get the most out of the show by connecting with us on Twitter, Facebook , LinkedIn and a Google+.

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What’s on tap for Thursday at INTERPHEX?

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What’s on tap for Thursday?

As INTERPHEX 2014 winds down tomorrow, be sure to take advantage all of the free sessions at INTERPHEX Connects, such as The 7 Characteristics of a World Class Supply Chain sponsored by Contract Pharma, a roundtable discussion on new approaches to downstream processing, sponsored by BioProcess International, and a presentation on CMO selection and successful tech transfer for aseptic fill and finish services, brought to you by Pharmaceutical Processing.

Thursday will bring attendees two final PDA Education sessions on pharmaceutical water systems and closing plenary-aging facilities. President of PDA, Richard Johnson, will also give his closing remarks, reflecting on the program’s first year.

If you haven’t had a chance yet, check out the Life Science Connect Radio at pharmaceuticalonline.com – radio hosts will be streaming interviews with attendees, exhibitors, and subject matter experts live from the show floor.

Have a great last day at INTERPHEX tomorrow!

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Day 1 of INTERPHEX 2014

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INTERPHEX, sponsored by PDA, Day One Update

Day one of the biggest pharmaceutical and biopharmaceutical show of the year is under our belts, and what a day it has been! We kicked off INTERPHEX, sponsored by PDA with a Grand Opening ceremony presented by Pump Solutions Group – complete with live music from the Norwalk, CT marching band and a celebratory toast from some of the industry leaders.

PDA Education Sessions
The PDA Education@INTERPHEX series started off with welcome remarks from PDA’s President, Richard Johnson.

“All of you are very special – you are attendees of the first ever PDA education program,” Johnson said. “Thank you to all of the planning committee, staff and speakers.”

Morning education sessions, focused on industry trends and regulatory expectations. Speakers discussed expectations and explored trends focused on the use of technology, risk based decision-making, process capability, and quality systems need to achieve manufacturing excellence.

One of the highlights of the afternoon was a PDA session on biopharmaceutical and sterile manufacturing. Andrew Birkmire of GEA Process Engineering gave a great talk on aseptic spray drying as an alternative to lyophilization, and Morris Phelan of GE Healthcare Life Sciences discussed single-use technologies as an enabler when secure becomes safe in aseptic processing. Phelan said that big data is a revolution that will transform how we live, work and think. The days of red, yellow, green scorecards and ways of ranking risk are over – we have to take a big swing at big data.

Phelan was also excited to check out the 650+ exhibitors on the show floor after this presentation. “I can’t wait to get upstairs to see what’s new,” he said.

On the INTERPHEX Show Floor Representing All Dosage Forms
There were a lot of great products showcased today, including the EnteriGel softgels from Aenova that offer enteric delivery without additional coatings, and the new HyPerforma Single Use Bioreactor from Thermo Fisher. Jewett Automation was demoing their Robotic Arm hitting a golf ball, and the Federal Equipment booth was giving out free rides in their F1 racecar. Industry professionals also had the chance to hang out with peers at the ILC Dover booth modeling their Sentenial XT PAPR lightweight panoramic hoods that improve worker safety and productivity.

Throughout the day, the INTERPHEX Connects Innovation Stage area was bustling about with people. New to the show this year, the three stages feature free sessions, roundtables, panel discussions and keynote presentations.

What’s on tap for Wednesday?
Tomorrow, in addition to the robust PDA Education lineup, IPS Integrated Project Services will be leading the IPS Technologies Floor Tours at INTERPHEX. Attendees will gain insight into the latest equipment, innovation, and manufacturing technologies offered by leading vendors and internationally recognized experts.

“INTERPHEX truly is an enabler for us, helping bring together clients and the vendor community,” said Dave Goswami, Chairman and CEO of IPS. “Our technologies floor tours are a great way to connect everyone.”

Also on tap for tomorrow is a full line-up of free education sessions on the Innovation Stages at INTERPHEX Connects, Case Study Series and Workshops. Wednesday will also feature leading edge Specialty Forums like the State of the CMO Industry 2014, sponsored by PharmTech Magazine.

Day two of the show will conclude with the INTERPHEX St. Patrick’s + 2 Industry Celebration, Wednesday evening from 5-7pm at the River Pavilion. This can’t miss event – brought to you by Thermo Fisher – will feature live music, a golf simulator contest, photo booth, cocktails and hors d’oeuvres.

See you tomorrow!

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Phex Phriday Press Release: Patheon and DSM Combine Capabilities

DPx Launches as Global Provider of Pharmaceutical Services, Fine Chemicals and Proprietary Technologies

$2.65 billion transaction combines the capabilities and expertise of Patheon and DSM Pharmaceutical Products to create industry powerhouse

Durham, N.C. — (March 11, 2014)—DPx Holdings B.V. (DPx), privately owned by JLL Partners and Royal DSM, today launched as a leading global contract development and manufacturing organization (CDMO) for the pharmaceutical and related industries. DPx is the result of a USD $2.65 billion transaction between JLL Partners, a leading middle-market private equity firm, and Royal DSM, the global Life Sciences and Materials Sciences company. DPx is 51 percent owned by JLL Partners and 49 percent by Royal DSM. With headquarters in Durham, N.C., DPx’s global footprint includes 24 locations across North America, Europe, Latin America and Australia with more than 8,000 employees.

Formerly known by its provisional name “NewCo,” DPx is the corporate parent of a group of business units that is comprised of three distinct brands focused on pharmaceutical services, fine chemicals and products and proprietary technologies. These units are the result of combining DSM Pharmaceutical Products (DPP), Patheon and Banner Life Sciences.  The company’s business unit structure is as follows:

  • Pharmaceutical services will operate under the Patheon brand name and include the commercial manufacturing (CMO) capabilities, pharmaceutical product development services (PDS) as well as Biosolutions and Biologics (Bio) businesses of DPP;
  • Fine chemicals, or the ES/IM and active pharmaceutical ingredients (API) businesses, which will operate under the brand name DSM Fine Chemicals; and
  • Proprietary products and technologies, which will operate under the Banner Life Sciences brand name.

Patheon is the industry’s end-to-end supplier providing an integrated supply chain model to customers. Patheon delivers a full spectrum of pharmaceutical development and manufacturing services ranging from active pharmaceutical ingredients (API), Biologics and Biosolutions, as well as pharmaceutical product development services (PDS) and commercial manufacturing (CMO) capabilities. Additionally, DSM Fine Chemicals will handle complicated APIs and finished dosage forms for customers while Banner Life Sciences will offer its own proprietary and nutraceutical products to the market.

“This is an exciting day for our customers and employees. We believe that combining the capabilities and experience of both Patheon and DPP immediately positions us as the pharmaceutical industry’s partner of choice,” said Jim Mullen, CEO of DPx. “Today we are better positioned to add scale, new value chain capabilities and technologies, as well as expand our end-to-end service offerings to our customers as a global, comprehensive solution provider to the industry.”

Learn more and read the complete press release here.

Visit Patheon at their booth (1438) and DSM at booth (1211) at INTERPHEX, March 18 to 20!

Get the most out of the show by connecting with us on TwitterFacebook , LinkedIn and Google+

 

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