ISPE and Bio Pharm Industry in India

Check out the India Affliate of the ISPE...over 50 new members in the past couple of months...

and they just had their big industry event...

ISPE India’s Annual Conference on Aseptic Manufacturing and Contamination Controls-Current Issues and Trends

Anybody out there have any news, infromation or feedback from this event to post???

Send me a link...

Baxter FOY Presentation

The presentation topic for the ISPE meeting last Thursday night was the winning entry for last Year’s Facility of the Year competition, which was the Baxter project…

It looked like it was going to be a well-attended meeting due to the interest in the modular construction presentation topic…

I arrived early at the Holiday Inn…the traffic in North Jersey is such that if you want to get there at all, you have to get there early…I wandered around, admiring the nice collection of Beaux Arts architectural prints on the walls…everybody else was on their cell phone…

I had a bit of a chat with Mr. Inoue….see link to that post here…Mr. Inoue also noted that modular construction techniques were difficult implement in Japan due to over-the-road restrictions on module sizes, especially height. He indicated that the technique had been successfully used in remote areas that did not have similar restrictions.

I spent some time talking to some people from T+M Engineering…They are currently working on a pre-cast project in Northern NJ. In keeping with the theme of the evening, we all agreed that the construction speed of a pre-cast structure was something to be seen…

Conversations broke up when it was time for dinner to be served…given the crowd, it was difficult to find a seat… I tried to find a table with an open place to sit but it turned out to be like little kids playing musical chairs, and I wound up losing my seat while I was in the buffet line anyway…of course, by then, all of the other seats were taken… I eventually found a seat when they got more tables in place…Obviously, they weren’t keeping track of how many people were coming in the door as compared to how many places were set… other than that, dinner was fine…

When the presentation started, Mr. Signore of IPS made a brief introduction…

Mr. Ulrich Rudow, Vice President of World Wide Engineering & Real Estate for J+J provided a discussion regarding the judging process used in the competition…I think this was the most interesting part of the presentation, particularly if you are interested in submitting a project for consideration in future competitions.

I think he indicated there were 30 applications the first year and 50 this past year…Mr. Rudow joked about how many times he read about “world class”, fast-track”, and “best-in-class”…

He indicated the judges were looking for the “Ah hah” factor, or the “why didn’t I think of that?” type of reaction…

During the judging process, project applications were eliminated due to wrong data or data that was not internally consistent through out the presentation. Projects with only vague information also got the boot, or if the judges felt information was being concealed. Another important criterion was that the facility needed to be “ready to make product” and completely validated. He discussed issues involved in maintaining impartiality during the judging process and efforts to avoid any conflict of interest during the review process…

He indicated that size was not the determining factor in selecting the finalists, and pointed to the spectrum of project sizes among the five finalists as an example of other criteria being more important.

During the final judging, Mr. Rudow indicated that a point system was used to score the various entries and that he found that the judges all arrived at the same conclusions and had developed a solid consensus by the 3rd round of judging….

I thought it interesting that Mr. Rudow noted that we all provide engineering in pretty much the same way and only “tiny little differences” were all that ultimately separated the various entries…

Mr. Rudow concluded his remarks by noting that the judging effort was a lot of work and a lot of fun…


At this point the presentation was tuned over to Mr. Gordon Leichter of the Pharmadule, Inc.

Mr. Leichter presented briefly presented the five finalists and presented the winning entry in more detail…

The FOY Competition evaluates project entries against the following criteria:

- safety,
- significant contribution to industry,
- unique and innovative approaches
- quality
- project management techniques


The Baxter Project combined modular stick-built construction techniques with new construction of an addition and renovation of an existing structure.

Mr. Leichter indicated that a critical part of the project success was that the client had prior experience with modular construction with Pharmadule and understood the process of working within the requirements of this approach…

Mr. Leichter made a very interesting presentation, which included a lot of good pictures of the actual construction of both the module fabrication and field construction activities.…

The modular approach allowed site preparation activities to be undertaken while modules were being fabricated off-site…so far off-site, it was fabricated in another country…that’s off-site…

Modular construction does seem to go very quickly in the field. Mr. Leichter indicated that 6 modules were placed per day with the project being comprised of 62 total modules arranged in a three story layout…Overall module size was 14’-6” x 14’-6” x 45’ long, and this size was determined by over-the-road transportation restrictions…I found it interesting that Pharmadule also validated the facility as part of their project scope.

It appeared that more than one full year of conceptual and preliminary design time was not included in the reported project schedule for the competition… assuming I understood the presentation correctly…I am very surprised the judging committee did not focus on this issue more closely…

A young lady asked an interesting question regarding at what point in the project did the decision to apply to the FOY take place…I was also wondering if you start out the project with this as a goal in mind, or if you wind up realizing you have a candidate project after the fact…I didn’t quite follow Mr. Leichter’s answer…

Various other questions came up around other issues involved in modular approach to project execution and the trend toward this approach…Mr. Leichter indicated that modular execution would be a paradigm shift for most project teams…

It was noted that equipment layout must be coordinated with module layout in this construction technique…particularly for larger equipment like autoclaves or lyophilizers, and spread out equipment like the filling line set-ups …

The obvious question regarding cost premium came up and Mr. Leichter indicated it was quite a common question. He was understandably reluctant to quote an exact figure but indicated that a 10-15% premium could be expected after the completion of a conceptual layout.

Other issues came up regarding risk associated with this approach to project execution… Reaction at my table was that the risks involved in this type of approach were not discussed or addressed as part of the presentation.

In looking at the brochure material handed out as part of the presentation, there were more projects executed in this manner that I would have thought, although I am not sure how many have been successfully completed in the U.S…most seemed to be located in Europe.

Reaction from the audience indicated that most everyone felt it was an interesting presentation…

Clearly more answers to specific questions are needed to completely evaluate the modular approach to capital project execution…more than can be raised at a dinner meeting sales presentation… and more than can be covered here…

An interesting topic, which I am sure will be discussed in much more detail in the future…I am also sure other projects are being considered for execution in this manner and we should follow the progress of these projects carefully for more information.

Obviously, modular construction is a growing trend and is attracting a lot of interest, even if you only judge based on the size of the crowd in attendance…

More information can be found at the Pharmadule website at www.pharmadule.com

My conversation with Mr. Inoue

While attending the ISPE meeting last Thursday night, I had the pleasure of meeting Mr. Mikio Inoue. We wound up having a pleasant conversation regarding his involvement with the competition and some other aspects of the pharm/bio industry.

We had both arrived at the meeting early and were waiting for the festivities to begin and I took the opportunity to introduce myself. We were exchanging pleasantries typical of being just introduced at a meeting and discussing the fact that it seemed like it was going to be crowded based on the Baxter FOY presentation.

Look for a review of that presentation coming shortly…


Mr. Inoue mentioned that he had been involved in the FOY competition (website link) and he was attending tonight to provide local representation for the project and his company.

I noticed he had a Facility of the Year sweatshirt on and we began to discuss his involvement with the competition.

It dawned on me that this was going to be a better conversation than the usual “Consultant meets Vendor at an industry function”... you know the type….we’ve all had a million of them…
With his permission I started scrawling some notes…I hope this captures the basics of our conversation, I do not have any actual training as a reporter, so bear with me…

Mr. Inoue had participated in a very successful project for the Daiichi Asubio Pharma Co., Ltd (website link). The project is a multi-product production facility located in Gunma Prefecture, Japan. Descriptions of the five finalist projects are available here at the FOY website (website link).

The project was a finalist in the 2006 Facility of the Year competition, which is how he got the sweatshirt. The competition is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

He was very knowledgeable about the project and had a lot of detailed information regarding building layout, processes, and equipment involved in the project. The facility is capable of multi-product and multi-scale production and launch operations. The major pieces of process equipment were provided from a very geographically diverse set of countries. Mr. Inoue stated that part of the success of the project was having the architect understand the process to be supported by the facility.

Mr. Inoue indicated that the project was reviewed with the FDA in order to align the project with regulatory expectations. We both agreed that a Type C Meeting with the FDA is a very valuable step and allows for valuable input to be provided by the FDA in a more casual setting.


He was very knowledgeable about the project type and had some interesting rules of thumb regarding building size and process valve count. We also discussed the level of automation a project might have based on differences in approach between the level of automation between Japanese and US approaches to plant operation.

Mr. Inoue described the typical Japanese approach of using a high level of automation and centralized DCS systems in order to limit manual interaction of the operators in the production process. This approach also reduces labor costs associated with the plant operators and also addresses the difficulties of staffing a plant with operations personnel.

This approach is in contrast to the equipment specific PLC/ “islands of automation” approach that is often found in plants built here in the US. This results in less centralized control, beyond data gathering, and more manual interactions with the process. We discussed how the US approach may be driven by an operating company’s regulatory history, risk aversion, perceived complexities and costs of validation efforts associated with complex automation and control systems.

Both approaches are driven by the need to respond to the expense and availability of operator labor. While these are not hard and fast approaches, it represents a philosophical difference in each countries typical approach to the industry.


Mr. Inoue holds a PhD and is the General Manager of the Pharmaceutical & Biotechnology Project Division for the Fujikin of America Inc.

Mr. Inoue has recently moved to the US and is living and working in New Jersey. When asked how he found living in NJ, he replied “tough…” When I heard his response, my first thought was “well, it is New Jersey…” home of the Sopranos, the Jersey Turnpike, and the Attitude Capital of the World…

Mr. Inoue indicated he is very involved in the ISPE New Jersey Chapter activities. He had attended the Holiday Cruise party and would also be going to the Nets- Spurs game coming up on date.

Mr. Inoue can be contacted by phone at (201) 641-1119 or via e-mail at minoue AT fujikin.com. (substitute the "@" symbol for e-mail address...)


I guess I should try to introduce myself to more people more often when I go to ISPE meetings.
A lot of highly qualified and experienced people attend and I would probably be able to have a lot of interesting conversations.

I consider myself lucky to have met Mr. Inoue and to have had such an interesting conversation.