Hal Smith

Cleanroom disposables such as gloves, wipers, swabs, garments, and packaging, are high volume items which often come in direct contact with contamination-sensitive materials. Because of this they are required to have many properties not associated with the same items used outside the cleanroom. Cleanliness requirements include minimum particle and fiber counts, organic and non-ionic extractables, and outgassing products as well as redeposition of wiped up materials from cleaned surfaces and low levels of deposition by contact transfer.

The construction of these materials must not lead to contamination. For example, the seams on sewn cleanroom garments must used flat-felled seams or equivalent methods to enclose the rough edges of the cut cloth. The edges of the higher cleanliness wipers are sealed to minimize particle and fiber generation. All this in addition to the normal requirements of the disposables as many face the same safety and performance criteria of non-cleanroom materials.

Cleanroom garments are designed to protect the environment from the wearer. If there are safety issues, additional garments may be required. Garments are made either from woven or non-woven materials. Woven materials are more porous, in general, than non-woven and are usually launderable for many times. Membrane based garments (non-woven) are launderable about as many times as woven. The hoods, boots, and face masks must conform to the same cleanliness standards as frocks and coveralls. Laundering cleanroom garments requires special equipment, high resistance de-ionized water, clean packaging, special cleaning agents, cleanrooms, and, in some instances, sanitizing.

Cleanroom wipers and swabs are usually made from cleaned/processed materials commonly sold on the market. Natural materials tend to be less clean and more sorptive than synthetic. Wipers must reduce the number of shed fibers.Wipers are made from either woven or non-woven (foam, hydro-tangled or spun-bonded) materials. The requirements for cleanliness far exceed their non-clean kin, often by a factor of a 1000. Currently, wiper and swab manufacturers are working to increase cleanliness while keeping sorption as high as possible. Solvents extract non-volatile residues (NVR) which cloud optics and IC wafers, while water extracts ions which are harmful to IC wafers and disc drives.

Cleanroom gloves, excluding knit/woven, are barrier gloves made from a variety of polymer or copolymer bases each of which possess unique properties of cleanliness, chemical resistance, outgassing, etc. Some polymers are inexpensive but suffer excessive NVR or are inherently dirty. Others are extremely expensive but may be ultrathin, solvent, but not water resistant, etc. Gloves are made in various thicknesses according to usage. Thermal-resistant and ESD gloves are available for cleanroom use. The selection process must consider the many variables, some of which are mentioned above. Only by trial and error, in many cases, are suitable disposables selected.

Nordic News Åke Möller

THE INTERNATIONAL SYMPOSIUM IS COMING TO COPENHAGEN

The 15th Symposium of the International Confederation of Contamination Control Societies, which is held every two years in different parts of the world, will take place in the year 2000 in Denmark from the 14th until the 18th of May. As with the last Symposium to be held there in 1976, it is being organized by R3-NORDIC and the tremendous amount of work involved in making all the arrangements is already well advanced. Once again it will be held in 'Wonderful, wonderful Copenhagen' against the backdrop of all that that means in the springtime. The venue is the Radisson SAS Falconer Center.

The last time, at the 3rd Symposium, R3-NORDIC had 340 members and a slim budget. This time around, it has 1,600 members and a healthy economy. Much else, of course has changed in the interval. Symposium 2000 will be a very comprehensive event with its associated exhibition of every modern aid to the effective and efficient cleanroom, plus a full programme of papers, discussions and tutorials. In addition, we now have the Internet to help with the marketing, and the ICCCS web-site to provide everyone with advance information. This is particularly valuable to those countries that do not have a contamination control society. The web-site is well worth a visit: just get to www.icccs.org and click 'Symposium'. (You will see at the same time that there are quite a few other interesting links as well!) A First Announcement and Call for Papers were made to ICCCS member societies last autumn but the present position can be found on the web-site along with details for contacting the organizers by post, fax or e-mail. The Call for Papers set a submission deadline of 30th July but there may still be a chance to make a contribution.

Papers are organized around the themes of Semiconductor Electronics, Pharmacy, Medical Devices and R3-NORDICís special interests in Food and Mechanics. Each of these is divided into about five subheadings. The last day is scheduled to have tutorials on each of the 11 documents of the ISO group of standards on Cleanroom Technology that are presently under construction or newly completed. By the beginning of September, R3-NORDIC had received over 70 interesting abstracts for the first three days of the Symposium and these are at present being appraised. Titles and perhaps some of the abstracts will be found in the comprehensive Second Announcement which will be distributed by R3-NORDIC in early November. The web-site information will also be updated at that time.

The relatively new interest in the cleanroom technology of food continues to grow and there are a lot of Nordic experts in the field who will have interesting things to say on the subject. World-wide, there are very many in the food industry who need access to a knowledge of modern methods of contamination control.

R3-NORDIC, from its inception, has taken a great interest in Mechanics and, indeed some of the Societyís earliest members came from the aircraft maintenance industry. Many aspects of engineering benefit from the application of contamination control techniques and all kinds of things from ball-bearing manufacture to paint spraying in the automobile industry make use of it. This sector will be well represented at the Symposium also.

There will be a Welcoming Reception on the Sunday at 7 p.m. See you there!

International Standards

Cleanroom standards being produced for world use by the International Organization for Standardization Technical Committee 209 are progressing.

The defined development stages carry prefixes as follows:

The following ISO/TC209 documents are at the stages described:

Drafts issued by BSI for public comment in the United Kingdom

The present situation is as follows

European Standards

British Standards

Publicly available documents covered in this update report can be obtained from: BSI Standards, 389 Chiswick High Road, London, W4 4AL. Sales Tel: 0181-996 7000, Sales Fax: 0181-996 7001.

'Baseline Pharmaceutical Engineering Guide - Pharmaceutical Engineering Guides for New and Renovated Facilities. Volume 3 Sterile Manufacturing Facilities, First Edition 1999'.

The International Society of Pharmaceutical Engineers (ISPE) has recently produced the third volume of their Baseline series of pharmaceutical engineering guides. They have embarked on an ambitious programme of writing 10 guides to assist those planning pharmaceutical manufacturing facilities. Eight of the guides will assist in the design, construction, commissioning and qualification of facilities such as bulk chemicals, oral solid dosage, sterile manufacturing etc. The others will cover (a) water and steam systems and (b) commissioning and qualification. Only a few of these Guides are complete and I have reviewed the volume dealing with Sterile Manufacturing Facilities.

As might be expected from a Society whose headquarters is based in the USA, these Guides have been primarily written to meet the requirements set by the FDA. They will therefore be especially attractive to European manufacturers who wish to manufacture products for sale in the USA and hence require FDA approval. Approval from the FDA is inevitably much more of an unknown than approval from the local inspectors and hence this Guide will be very helpful. The ISPE Guide modestly says that it may be helpful to manufacturers meeting European requirements. I think that it would be very useful in fulfilling European requirements, although there are clearly some differences in approach. For example, the Guide is said to provide information for the building of facilities for manufacture of aseptically produced and terminally sterilised products. In reality, there is little difference drawn between the design of the two types of facilities in the Guide. This may reflect the (incorrect in my consideration) expectations of the FDA but these occasional deviations make it only slightly less useful for European manufacturers. The fact that the Guide spans the practices in the USA and Europe must be due to the task being carried out by a European team lead by Bruce Davis from Zeneca, assisted by Jim Durkin from Pharmaplan.

I should like to draw readers' attention to the fact that the FDA has read and commented on the Guide. The Guide has a disclaimer that says that a facility built in accordance with the Guide may not be acceptable to the FDA but I have no doubt that they will be very close.

Another principle of this Guide is one of ensuring a cost-effective design. Many designers, unsure of the requirements of the FDA, are inclined to over-design and create over expenditure. This Guide is written with this in mind and I particularly noted that the section on construction and surface finishes was most helpful.

The Guide is 162 pages long and contains sound, relevant data. One does not lose interest, as can occur in so many other books and guides. This no doubt reflects well on the authors writing style but my experience in writing with Engineers leads me to believe that the technical co-ordinators and editors have made a significant contribution. I reproduce one difficult sentence that I noted. This was a rarity and only included to lighten the reading of this review. The sentence was:

"This affects the calculations of air change rates to off-set particulate gains, and, in particular, recovery periods, as the particle count differential, to the 'at rest' condition, may be small".

The Guide contains chapters on: concepts and regulatory philosophy; process and equipment considerations; architecture and layout; HVCA; utility systems; electrical services; control and instrumentation; cleaning; engineering issues; barrier-isolator technology; general considerations and commissioning and qualification. It also contains appendixes on HVAC-European considerations and HVAC- additional engineering information. These chapters and appendixes give basic practical information that will be of great assistance to those involved in either renovating or building new sterile manufacturing facilities. It is helpful by covering problems that are causing current debate.

If you are not a member of ISPE, the cost of this Guide is a hefty $405. A member will pay a more modest $250. This seems expensive for a soft-back book and I am pleased to report that I received a free copy to review. It will remain on my bookshelf. It is an excellent book for any pharmaceutical manufacturing or facilities design company to buy.

W Whyte University of Glasgow

Future Issues

Please keep the letters coming through and remember that articles are always in demand. If you would like to contribute, please contact:

Torn Hindmarch
North Tyneside College, Embleton Avenue, Wallsend, Tyne/Wear, NE28 9NJ

Phone: 01912295255; Fax: 01912295301

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