TABLE OF CONTENTS

CONVENTIONS

6500 Attendees at Lounges Last Month in Karlsruhe

ISPE offers 7 Training Courses Next Week in San Francisco

Pharma Congress in Dusseldorf will feature asceptic technologies and barrier systems.

More Cleanroom Exhibits this Month in Stuttgart

Biggest French Cleanroom Show is also Scheduled for this Month

Interphex in New York Will Have Many Exhibitors of Clothing and Hardware

April and May Will also be Busy

Interphex has a Strong Program with Cleanroom Presentations

TECHNOLOGY

Tech Transfer from Pharma to Hospitals

Rahe Recommends Cleanroom Technology to Hospitals

INDUSTRY NEWS

Reinraum On-line Provides Great Coverage of German Cleanroom Activities

Valutek Launches Reusable Glove that Breathes

Eurofin to Acquire Lancaster Labs for $200 Million

Biotest 2010 Sales were up by more than 5 Percent

Cintas Provides an Example of the BizKnowNet Ability to Provide Better Networking at a Show

ALSCO Opening New Facility with ISO 4 Cleanroom in Regensburg

NETWORKING AT THE SHOW

Exhibitors at Interphex

Exhibitors at PHARMA CONGRESS 2011

Speakers at FILTECH 2011

CONVENTIONS

6500 Attendees at Lounges Last Month in Karlsruhe

Dr. Hans Schicht had a chance to talk to many of you at the Lounges exhibition and conference last month. Some 6500 visitors toured stands manned by 210 exhibitor companies and attended 200 lectures that ranged the gamut from tutorials to expert sessions.

The action stage was an additional feature. Carsten Moschner of Dastex utilized a body box and live model to demonstrate the particle shedding characteristics of garment wearers.

Eighty percent of the visitors came from pharmaceutical and biotechnology manufacturing, 15 percent were involved in food processing. The number of international visitors rose to almost 10 percent this year. Next year Lounges will be again held in Karlsruhe from February 28, March l, 2012.

One of the assignments we gave Dr. Schicht was to pursue the debate about garment choices for cleanrooms. We have provided differing points of views on the free website.

A number of exhibitors displayed garments. There was a general preference for reusable garments except for maintenance, or temporary workers. One pharmaceutical facility Sanofi-Adventis in Frankfurt-Hoschst uses both disposables and reusables. They have a number of temporary workers due to their fluctuating business. These workers wear the disposable garments.

Two fabrics are most prominent in disposables. DuPont Tyvek with smooth surfaces inside and out is recommended for air cleanliness classes of ISO 7 and higher (less clean); Kimberly-Clark Kimtech Pure A5 is specified for air cleanliness class ISO 5. It is manufactured from nonwoven SMS material, however, with less smooth surfaces inside and out. The product is promoted by VWR, who believe it has a lower particle shedding characteristic. The opposite observation was made by another knowledgeable exhibitor who says that the KCC product has higher particle shedding characteristics, so this is definitely an area that needs further research.

Two Companies offering both kinds of garments are Basan/Intersteri and, Dastex. Both are selling fewer disposables. One reason is that disposables are perceived as less comfortable, less flexible in sizing, as no suitable disposables are available for very small, very tall and very overweight staff, and less desirable from the ecological point of view. Also thermal comfort is mentioned as somewhat lacking in disposables:  a lower room temperature is required in comparison with reusables.

The sustainability aspect was mentioned by a number of people. The concept is that disposables are less harmful to the environment than reusables. (Note:  McIlvaine has prepared a lengthy analysis to show that this is not necessarily so and depends on whether waste is utilized in a waste-to-energy plant and whether the alternative reusable washing system minimizes water pollutants.) Regardless of the facts this is a factor in the preference for reusables.

Dr. Schicht also interviewed companies who serve the cleanroom industry and must therefore wear cleanroom garments.

Profi-con is a leader in cleaning of sterile facilities. It works exclusively with company-owned personalized reusable garments, except if the customers wish otherwise. Their uniforms are prominently marked with the company logo.

COWA employs Tyvek for the first cleaning stage of a new or remodeled facility, i.e. when the surface contamination level is still relatively high. The second cleaning stage which must lead to the specified surface cleanliness level of the clean area is then performed in the same garments as during routine cleaning; reusable garments in all cases. Garments are almost always provided by the customer.

Berendsen, a provider of garment leasing services, also runs a cleanroom cleaning division. In line with the core business, only reusable garments are worn by the cleaning personnel.

WZB, a workshop for the handicapped, manufactures and launders cleanroom garments. As laundering is their core business, they only market reusables, and consider disposables as “ecological disasters”.

Companies providing testing and validation also were interviewed. PMT ,a leading German provider of measurement and testing services in cleanrooms (qualifications and verifications), works exclusively in disposable garments during measurements in classified areas. They purchase them from Veltek Inc., USA, as they are the Veltek representative for Germany.

CAS, a leading Swiss provider of cleanroom measurement services with branch offices in Germany and Austria, takes a different view. In Germany as well as in Switzerland, their customers normally provide the garments for the measurement team. In a way, their personnel is treated just like other visitors and follows the corresponding customers’ rules. In Germany, the split is, as a general rule, 50 percent disposables, 50 percent reusables. For extended and frequent measurement commitments, the split is rather 70 percent reusable, 30 percent disposable garments; for short and minor assignments, it is 70 percent disposables.

In Switzerland, on the other hand, in 90 percent of the pharma assignments disposables are given preference, the material being almost always Tyvek and it is as a rule specified by the customer. Small pharma companies show the same preferences as the large companies such as Roche and Cilag.

In the hospital field in Switzerland, the garments for the measurement personnel are almost always unpersonalized reusables.

Basan/Intersteri mentioned one application where exclusively disposables (Tyvek) were used. It is an ISO 5 facility for the assembly of spacecraft components but it is not known whether the classification means at rest or in operation.

Christian Moschner of Dastex supplied a number of insights. In general the disposables shed more particles than reusables. Due to the recent market conditions there has been an increase in the imports of poorer quality garments. The financial crisis has transferred more power to the purchasing people and away from the operators and quality control personnel. Howeve, the pharmaceutical industry has opted for high quality. Dastex has retained a high share of this market. Moschner recommends disposable garments for:

·         handling of cytotoxics (here, no alternative exists);

·         visitors of all kinds to classified areas;

·         service personnel.

Moschner believes that company maintenance personnel should wear disposables as the risk of damaging and soiling the garment is very high. On the other hand, he is strictly against the use of disposable garments during the execution of qualification and verification services in cleanrooms. The particle shedding of these garments will inevitably prejudice the measurement results.

ISPE offers 7 Training Courses Next Week in San Francisco

ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced that it will offer seven training courses, including sessions focusing on biotechnology and Good Manufacturing Practices (GMP) at its San Francisco Professional Development Training event to be held March 7-10, 2011 at the Hotel Monaco San Francisco in San Francisco, CA.

This marks the first time the ISPE training event has returned to the San Francisco area since 2007. As a member-based organization, ISPE draws from the expertise of its members to develop training courses that address industry demands and to provide in-depth knowledge on a specific topic. Many courses utilize case studies, team exercises and ISPE guidance documents to immediately apply the learning objectives to real-life situations within their own organizations.

One of the event highlights will be the intermediate-level course, “An Overview of Biopharmaceutical Manufacturing Processes,” led by top biotechnology consultant and industry expert Mark Witcher, PhD. The course will survey commonly used biopharmaceutical manufacturing practices, including cell culture and fermentation, harvest and recovery, viral removal and inactivation, and purification processes. The increased use of biopharmaceutical manufacturing processes makes this course highly recommended for individuals responsible for process design, process validation, and equipment design and selection for biopharmaceutical applications. Management, supervisory, and engineering personnel beginning work in biopharmaceutical product development, production operations, quality assurance and regulatory compliance are also encouraged to attend, as is anyone with an interest in learning how biopharmaceutical manufacturing processes work.

The course, “Q7A:  Implementing Good Manufacturing Processes” is expected to be another top draw of the Professional Development Training event. Led by engineering design expert Jeffery Odum of NCBioSource USA, the course focuses on the compliance issues unique to biotechnology and pharmaceutical companies that manufacture active pharmaceutical ingredients (API). The course will review and interpret the key GMP requirements specific to bulk biopharmaceuticals and familiarize participants with the USFDA’s interpretation of ICH Q7 as defined in the Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Professionals in quality assurance, quality control, development and manufacturing, facilities engineering and maintenance, manufacturing equipment and systems design and production, and regulatory roles related to the production of API are encouraged to attend.

In addition to these courses, the San Francisco Professional Development Training event will feature courses on Pharmaceutical Water Generation, HVAC, Pharmaceutical Water Storage and Distribution, Cleaning Validation Principles, and Oral Solid Dosage Forms.

In addition to Witcher and Odum, top industry experts Rebecca Brewer – Dober Group, Jack Chu – Merck, Andrew Collentro – Water Consulting Specialists, and Norman Goldschmidt – Genesis Engineers will share their expertise and answer questions from attendees.

The impact of the recently updated USFDA guidance on Process Validation will be discussed during the classes to provide participants with the tools and knowledge needed to solve daily work-related challenges resulting from the Guidance’s significant changes.

For more information click here ISPE

Pharma Congress in Dusseldorf will feature asceptic technologies and barrier systems.

More Cleanroom Exhibits this Month in Stuttgart

In our free system you will see the following display when you click on 3C Europe.

The directory lists the following numbers of exhibitors under Cleanrooms:

Air Filters/Showers/Ionisers/Pressure controls (2)

Ceilings, Ducts & Exhausts (1)

Cleaning Systems (5)

Cleanroom Equipment, supplies and services (12)

Clothing (Cleanroom) (1)

Filtration Systems (3)

Fume Cupboards (1)

Furniture (Cleanroom) (3)

Glove Boxes (1)

HVAC Systems (1)

Laminar Flow Systems (7)

Mini Environments (4)

Modular Cleanrooms (6)

Others (8)

Biggest French Cleanroom Show is also Scheduled for this Month

Interphex in New York Will Have Many Exhibitors of Clothing and Hardware

April and May Will also be Busy

Click on the links and learn about three more cleanroom conferences in April and May. We will provide more details in Cleanroom Insights # 4.

Interphex has a Strong Program with Cleanroom Presentations

Here are details on some of the sessions on cleanroom subjects on the docket. Just click on the titles.

Data Search by Event

TECHNOLOGY

Tech Transfer from Pharma to Hospitals

Precision Air Products has done quite a bit of research into the incorporation of cleanroom techniques to the hospital industry they point out that:

Hospital Acquired Infections (HAIs) are a serious problem facing ALL medical facilities around the world. The CDC estimates 100,000 annual deaths from HAIs in the U.S. alone (more than double the amount killed in car accidents!). There are countless factors that can cause infections — the quality of the air should not be one of them. Doctors and medical staff have plenty to worry about managing surgical procedures — let's not add air quality to their list. Unfortunately, many operating rooms are designed without consideration of recommended airflow patterns that serve to minimize the effects of dangerous airborne particulate. Call us to learn more.

They advise hospitals that BEFORE designing the next OR suite, be sure to read up on ASHRAE 170.

Section 2.1-7.2.3.4 of the 2010 “Guidelines for Design and Construction of Healthcare Facilities” addresses ceilings for restricted areas. New since the 2006 Guidelines, Appendix A2.1-7.2.3.4 states that integrated, single assembly central laminar airflow diffuser arrays are not considered part of the monolithic ceiling and acceptable provided that:  1) The array is gasketed between the diffuser array system and the ceiling. 2) The array includes gasketing between the laminar airflow diffusers and its framing. 3) Fill-in panels are gasketed at the framing and at the perimeter of any penetrations made to accommodate ceiling mounted equipment. As in previous versions, ceilings should be scrubbable and capable of withstanding the harshness of cleaning and/or disinfecting chemicals commonly used for operating rooms. Integrated OR ceiling ventilation systems must meet additional requirements detailed in ASHRAE Standard 170, 2008 (Integrated into the 2010 Guidelines as Section 6, “Ventilation of Healthcare Facilities”. For additional information, please refer to:  www.fgiguidelines.org

Rahe Recommends Cleanroom Technology to Hospitals

Two years ago Hank Rahe, of Containment Technologies Group, Inc. published his analysis of hospital aceptic practices. He shares the McIlvaine view that hospitals can learn a great deal from the pharmaceutical manufacturers.

Hospital's aseptic practices don't even cover the basics. He observes that aseptic and sterile techniques and practices are not implemented in a number of critical areas of hospital facilities. The practice of sterilization and good aseptic technique is necessary for the control of infectious diseases. Three areas within the hospital facility are critical to reducing the potential for spreading infection. These areas include patient receiving, surgery, and its supporting areas, and the pharmacy. The facility must be designed with contamination control in mind. Control of airborne particulate and cleanable surfaces are the two cornerstones to a successful contamination control program.

He cited a typical facility where the lobby area at the entrance is beautiful to behold. It has a massive, open atrium and staircase, which add zero value to patient care. In contrast, the emergency room suite was quite a different story. Most likely, an untrained eye would not see the problems that create a high level of concern for contamination control in such a setting. The ceiling was inlaid acoustical and in no way was cleanable. Several areas had tiles that were slightly lifted. The air handling system had a single ceiling duct and seemed to use the hallway as a return. There were several surfaces in the room where contamination could collect and spread from patient to patient. The "dust bunnies" hanging from the sprinkler head and the ceiling framework reinforced this fact.

Is it any wonder that nosocomial infections are on the increase, when hospital facilities have such significant lapses in contamination control design? Airborne particulate, a primary source whereby disease is transmitted from person to person, is controlled through the use of HEPA or ULPA filtration. Proper room pressurization and controlled access will go a long way in containing the transfer of infectious disease.

Hank argues that a patient suite should be protected from outside contamination and the area outside the suite should be protected from any potential contamination that the patient may carry. To this end, the suite should have cleanable surfaces, controlled access and a way of controlling contamination by people. The two major sources of contamination by people are the hands and the feet. Individuals entering and leaving the potentially contaminated area should be required to wash their hands, don gloves and wear disposable shoe coverings.

Surgery suites and the areas that support the surgery, such as central sterilizing, are critical areas within the hospital in which the patient is most likely to be exposed to infection during a surgical procedure.

Cleanroom technology has been adapted in several hospital surgery suites as a means of particulate control, with a number of Class 1,000 and 10,000 rooms in use. There are several key questions that should be explored toward improving infection control in this area of the hospital. What incremental level of particulate control offers the best trade between cost and benefit? Are the engineering tools that are readily available being used to develop the best model for a surgery suite capable of reducing the potential of infection through particulate control?

Surgery suites are very dynamic areas having large stationary objects, such as overhead lights, which could potentially block the positive effects of the directional airflow. A significant amount of research is needed to model the impact of the dynamics and provide for the best location for both air inlets and returns.

In many hospitals, the central sterilizing area is responsible for preparation of the instruments used in the surgery. An interesting comparison, in the quality of environment and methods used, can be drawn between the hospital central sterilizing area and a pharmaceutical company preparation area for parenteral products. The comparison is intended to highlight critical areas for infection control. The basis for comparison is the standard facility and methods used in the pharmaceutical setting.

A. Cleaning of tools, instruments and components:

·         Is the washing of the materials accomplished with a validated method? A validated method is one that demonstrates a defined result and can be consistently repeated.

·         What is the quality of the water used in washing and final rinse of the compounds?

B. Preparation area for components before autoclaving:

·         Is the area used for wrapping instruments a Class 100 environment?

·         Are the components placed into containers, or bio shield, in such a configuration as to allow complete penetration of the steam resulting in a seven log reduction when challenged?

C. Autoclave:

·         What are the materials of construction of the autoclave chamber and tubing?

·         Has the autoclave been validated, in terms of temperature distribution?

·         Has the autoclave been validated in terms of sterilization, by demonstrating a seven log reduction of organisms?

·         Are validated load patterns used in the operation of the autoclave?

·         Does the autoclave have Class 100 environments at the entrance and discharge doors?

·         Is instrumentation and temperature mapping checked on a routine schedule?

D. Transfer of materials to the operating suite:

·         Is a controlled environment provided for transfer?

In most hospitals, the pharmacy is the area in which products that are given to the patient intravenously are prepared. This type of product is called parenteral and typically is delivered in one of the following forms; syringes, 100 ml plastic bags called piggy backs or larger volume bags ranging from 500 to 3,000 ml.

This form of patient delivery is very effective since the product is delivered directly to the body's distribution system, it can also result in a major infection control problem.

The Centers for Disease Control reported "lapses in hospital aseptic techniques and use of intravenous anesthetic were blamed for unusual outbreaks of bloodstream infections at seven hospitals."The authors concluded that because the medications involved support the rapid bacterial growth at room temperatures, strict aseptic techniques are essential during the handling of the products. Testing indicated that there was no contamination of unopened containers of product, while cultures from syringes in the use showed positive contamination.

What is the basic problem that would allow this to occur and does it go unnoticed in many cases in most hospitals? The hospital, by definition, is a facility with a higher potential for transmittal of infectious diseases. Without the proper level of filtration, air systems can become a carrier of bacteria and viruses. The pharmacy IV laminar flow hoods or Class II biological safety cabinets are placed in uncontrolled environments. This may put unrealistic expectations on the use of aseptic technique for infection control.

INDUSTRY NEWS

Reinraum On-line Provides Great Coverage of German Cleanroom Activities

Extensive coverage of Lounges is provided in the latest issue of Reinraum On-line. It is German but the pictures alone are worth the effort to subscribe to the free service. With Google Translate you can quickly read items of interest. Reinhold Schuster and his team interviewed and reported on the speeches and exhibits. There are interviews with Ulrich Rothgerber who was in charge of the Lounges event, Horst Wikens of Camfil Farr and Jurgen Fuchs of Forbo Flooring. You can register for this newsletter at the following link:

http://www.reinraum.de/cgi-bin/newsletter.pl?action=subscribe

Valutek Launches Reusable Glove that Breathes

Valutek say that a new reusable glove will eliminate worker complaints “Operators have three common complaints:  they are constrictive, causing hand fatigue; they are uncomfortable because they cause sweatiness; and they have a poor fit.

“It’s no surprise that due to these factors, operators are constantly looking for any excuse to remove them, causing disruption and potential contamination in critical environments.”

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The front of each glove is coated in ultra-clean polyurethane (PU) where the glove comes in contact with the product, while the back is coated with breathable nylon to enhance operator comfort.

CEO Greg Halland said, “You operate your controlled environment to ensure consistency of your product and research, and getting your operators to perform at their highest level is a demanding task. At Valutek, we get that. That’s why we’ve introduced the first glove designed with the operator’s comfort in mind,” Halland continued.

Eurofin to Acquire Lancaster Labs for $200 Million

Eurofins Scientific SE has signed a definitive agreement to acquire Lancaster, PA-based Lancaster Laboratories, Inc. from Thermo Fisher Scientific, Inc. for approximately US$200 million.

Lancaster Labs, which has approximately 1,100 employees in the United States and Ireland, is one of the leading environmental testing laboratories in addition to providing pharmaceutical product testing services and cGMP Quality Control (QC) in North America. Lancaster posted about $115 million in revenues in 2010 and has been growing rapidly over the last 50 years.

Eurofins said the acquisition will help it become the global leader in this very stable and recurring business and significantly enlarges its North American footprint. It further said the acquisition reinforces the scale and quality of service of its leadership on a wide range of laboratory activities for the pharmaceutical and biopharmaceutical industries in North America, Europe and Asia.

The transaction is expected to close in the next two or three months, subject to applicable regulatory approvals and customary closing conditions. According to Eurofins, implied EV/EBITDA multiple is in line with levels previously communicated for transactions of this size and Eurofins’ value-creation objectives. No site consolidations or restructuring costs are foreseen as a result of this acquisition, and the transaction should be immediately margin and EPS accretive for Eurofins.

Biotest 2010 Sales were up by more than 5 Percent

According to preliminary and unaudited figures, the Biotest Group (Plasma Proteins and Microbiological Monitoring) recorded sales of €461.2 million in the financial year 2010, an increase of 5.2 percent compared to the previous year (€438.6 million).

At an investor conference in Frankfurt last November the company made a power point presentation. Click here to view the presentation.

http://www.biotest.de/ww/en/pub/investor_relations.cfm

The presentation shows that Microbiology sales were up 10 percent for the first three quarters. The company is also expanding its manufacturing operations. Growth of Plasma Proteins is being achieved by expansion in Florida and Germany. The Bivigam expansion in Florida was completed in December 2010. Total spending was approximately US$40 million. Expansion of the filling and packaging facility in Dreieich was started in December 2010. Total spending was approximately €25 million.

In the microbiology sector, the company manufactures, markets and sells products for detection and identification of contaminants in controlled environments, including RCS Microbial Air Samplers and Agar Strips, HYCON Contact Slides, APC Airborne Particle Counters, as well as sterile, ready-prepared plated, bagged and bottled agar media from its daughter company, Heipha Dr. Mueller, GmbH. The company has recently introduced the ICR Swab designed for qualitative microbial presence/absence tests. It is ideal for monitoring surfaces that are inaccessible to contact plates. It is:

·         The Triple-bagged

·         γ-sterilized at 25-35 kGy

·         Low abrasion swab material

·         H₂O₂-impermeable inner bags

·         Hanging device integrated

·         Reduced contamination risk

·         Swab pre-moisturized with NaCl solution

·         No growth promoting residue on surfaces.

Kenneth Troia will be attending the Interphex show. He is President of Biotest Microbiology Corporation. You can network with him at

Cell:  +1 973 224 8712

Tel:  +1 973 298 8596

Toll Free:  +1 877 210 5103

Fax:  +1 973 625 9454

Email:  Kenneth.Troia@BiotestUSA.com

Cintas Provides an Example of the BizKnowNet Ability to Provide Better Networking at a Show

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ALSCO Opening New Facility with ISO 4 Cleanroom in Regensburg

At its Dresden site the family owned American Linen Supply Company (ALSCO) has 3 ISO 4 cleanrooms. Now it is building a cleanroom in Regensburg which will be in operation next month. The rooms are part of the cleaning and decontamination process for garments used in semiconductor and pharmaceutical manufacturing.

The processing is tracked with a fail-safe system using RFID chips and bar codes. The facilities meet the requirements of ISO 0001-2008. Certification is proved by the Industrial Union of Textile Service Association (INTEX), and the wfk Institute. Certified annually, the RABC system according to the European hygiene standards EN 14065 prepared in laundries Textiles - Konztrollsystem - biocontamination "for the recycling of textiles. The Holstein Institute confirmed ALSCO compliance with hygiene requirements according to RAL-GZ 992/1-3 and the testing laboratory certified DMT ALSCO annual conformity according to EN ISO 14644-1:1999 cleanroom classification, according to the ISO class 4.

NETWORKING AT THE SHOW

Exhibitors at Interphex

Exhibitors at PHARMA CONGRESS 2011

Speakers at FILTECH 2011

McIlvaine Company

Northfield, IL 60093-2743

Tel:  847-784-0012; Fax:  847-784-0061

E-mail:  editor@mcilvainecompany.com

Web site:  www.mcilvainecompany.com