- Email: [email protected]
Regulation - do we love it? Probably (not)
Editorial
Filtration+Separation January/February 2006
Regulation - do we love it? Probably (not). Filtration & Separation is covered in the Current Contents®/Engineering, Computing & Technology (CC®/EC&T) online database and in the Research Alert® current awareness service. Subscriptions The subscription price is US$340, ¥40,300, 304. This price is valid to the end of 2006, and includes air-speeded delivery worldwide. Frequency of publication: ten issues/year. Send remittance with order (made payable to Elsevier Ltd) to: The Oxford Fulfilment Centre, PO Box 800, Kidlington, Oxford OX5 1DX, UK. Tel: +44 (0)1865 843378; Fax: +44 (0)1865 843940 Missing issues: Responsibility cannot be accepted by the Publishers after six months. Filtration & Separation (ISSN 0015-1882) is published 10 times per year in January, March, October, May, June, July, October, October, November, December by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK. PERIODICALS POSTAGE paid at Rahway, NJ 07065, USA. POSTMASTER: Please send address corrections to Filtration & Separation, 365 Blair Road, Avenel, NJ 07001. The opinions expressed by individuals in this publication are not necessarily those of Elsevier, who shall not be held responsible for them. All trademarks acknowledged. ISSN 0015-1882/05 © 2006 Elsevier Ltd. All rights reserved. This journal and the individual contributions contained in it are protected under copyright by Elsevier Ltd, and the following terms and conditions apply to their use: Photocopying Single photocopies of single articles may be made for personal use as allowed by national copyright laws. Permission of the Publisher and payment of a fee is required for all other photocopying, including multiple or systematic copying, copying for advertising or promotional purposes, resale, and all forms of document delivery. Special rates are available for educational institutions that wish to make photocopies for non-profit educational classroom use. Permissions may be sought directly from Elsevier Science Global Rights Department, P.O. Box 800, Oxford OX5 1DX, UK; phone: (+44) 1865 843830, fax: (+44) 1865 853333, e-mail: [email protected]. You may also contact Global Rights directly through Elsevier's homepage (http://www.elsevier.com), by selecting 'Obtaining Permissions'. In the USA, users may clear permissions and make payments through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA; phone: (+1) (978) 7508400, fax: (+1) (978) 7504744, and in the UK through the Copyright Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London W1P 0LP, UK; phone: +44 (0)20 7631 5555; fax: +44 (0)20 7631 5500. Other countries may have a local reprographic rights agency for payments. Derivative Works Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal circulation within their institutions. Permission of the Publisher is required for resale or distribution outside the institution. Permission of the Publisher is required for all other derivative works, including compilations and translations. Electronic Storage or Usage Permission of the Publisher is required to store or use electronically any material contained in this journal, including any article or part of an article. Except as outlined above, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the Publisher. Address permissions requests to: Elsevier Science Global Rights Department, at the mail, fax and e-mail addresses noted above. Notice No responsibility is assumed by the Publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer.
The subject of regulation will see divided loyalties amongst our readership. As far as filtration and separation equipment manufacturers are concerned, regulation can offer a welcome boost to sales. The more standards that are applied to the environment and healthcare (dealing with safety for example) or drivers that necessitate optimisation in manufacturing – or greater attention to detail throughout a process – is positive for a filtration company. But as end users of filtration equipment know, regulation can prove both costly and difficult to implement. One industry in particular has had its fair share of regulation. The Life Sciences industry is a vast arena, where filtration and separation technology takes its place among arguably the widest range of processes of all the industrial sectors; ranging from simple chemical syntheses to complex drug production. The industry encompasses everything from pharmaceuticals – drug discovery, isolating and purifying target molecules of interest, through to preclinical and the different phases of scale up; drug delivery and medical products – how the drugs are administered; and of course the biosciences side that covers the laboratory processes. In addition, one could also add fine chemicals processing into this sector, including a whole range of speciality chemicals such as dyes and pigments, agrochemicals, paints, soaps and toiletries, and essential oils. It is, of course, impossible to cover all these areas in one issue, so we have tried to pick some areas that are particularly relevant to the filtration and separation processes within them. Our focus starts on page 20, with a look at high technology filtration in complex laboratory scenarios. We touch on the above regulatory conundrum on page 24, by offering an insight into how small clinical biomanufacturing facilities are finding life with the new clinical trials directive. Our applications this month include a look at how nonwovens and membranes are used within medical devices (page 30), as well as case studies looking at wastewater treatment in a pharmaceutical plant (page 28), and olive oil recovery from process wastewater (page 38). As ever, if we miss anything in our editorial coverage, get in touch. Best wishes
Free circulation enquiries Tower Publishing, Tower House, Sovereign Park, Market Harborough, Leicestershire, LE16 9EF. Filtration & Separation is published monthly by Elsevier Advanced Technology, PO Box 150, Kidlington, Oxford OX5 1AS, UK. The editor will be glad to consider contributions but no responsibility for the safe keeping or return of unsolicited material will be accepted. Filtration & Separation is a member of BPA International, the leading world auditor of business publications. Journal Number: 02127 Printed by: Headley Brothers Ltd, UK.
contact:
P.S This month’s “must reads” – an opinion column from Pall Life Sciences’ president Roberto Perez, and the inaugural Society Roundup column, with Mompei Shirato, president of the Filtration Society Japan Association.
ELSEVIER ADVANCED TECHNOLOGY PO Box 150, Kidlington, Oxford OX5 1AS, UK. Fax: +44 (0)1865 843971 or 843973.
Editor David Hopwood Tel: +44 (0)1865 843642 E-mail: [email protected] Assistant Editor Liz Nickels Tel: +44 (0)1865 843914 E-mail: [email protected]
Advertisement Manager Europe/USA Bart Crabbé Tel: +44 (0) 207 611 4150 E-mail: [email protected] Advertisement Sales Executive (Spain/Far East/UK): Sally Pye Tel: +44 (0) 1865 843081 E-mail: [email protected]
Advertising copy Tel: +44 (0) 1865 843819 Email: [email protected] Production/Design Controller Colin Williams
www.filtsep.com Product Finder Naomi Reeves Tel: +44 (0)1865 843271 Email: [email protected] Managing Director Mark Purvis
1
Filtration+Separation January/February 2006
Regulation - do we love it? Probably (not). Filtration & Separation is covered in the Current Contents®/Engineering, Computing & Technology (CC®/EC&T) online database and in the Research Alert® current awareness service. Subscriptions The subscription price is US$340, ¥40,300, 304. This price is valid to the end of 2006, and includes air-speeded delivery worldwide. Frequency of publication: ten issues/year. Send remittance with order (made payable to Elsevier Ltd) to: The Oxford Fulfilment Centre, PO Box 800, Kidlington, Oxford OX5 1DX, UK. Tel: +44 (0)1865 843378; Fax: +44 (0)1865 843940 Missing issues: Responsibility cannot be accepted by the Publishers after six months. Filtration & Separation (ISSN 0015-1882) is published 10 times per year in January, March, October, May, June, July, October, October, November, December by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK. PERIODICALS POSTAGE paid at Rahway, NJ 07065, USA. POSTMASTER: Please send address corrections to Filtration & Separation, 365 Blair Road, Avenel, NJ 07001. The opinions expressed by individuals in this publication are not necessarily those of Elsevier, who shall not be held responsible for them. All trademarks acknowledged. ISSN 0015-1882/05 © 2006 Elsevier Ltd. All rights reserved. This journal and the individual contributions contained in it are protected under copyright by Elsevier Ltd, and the following terms and conditions apply to their use: Photocopying Single photocopies of single articles may be made for personal use as allowed by national copyright laws. Permission of the Publisher and payment of a fee is required for all other photocopying, including multiple or systematic copying, copying for advertising or promotional purposes, resale, and all forms of document delivery. Special rates are available for educational institutions that wish to make photocopies for non-profit educational classroom use. Permissions may be sought directly from Elsevier Science Global Rights Department, P.O. Box 800, Oxford OX5 1DX, UK; phone: (+44) 1865 843830, fax: (+44) 1865 853333, e-mail: [email protected]. You may also contact Global Rights directly through Elsevier's homepage (http://www.elsevier.com), by selecting 'Obtaining Permissions'. In the USA, users may clear permissions and make payments through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA; phone: (+1) (978) 7508400, fax: (+1) (978) 7504744, and in the UK through the Copyright Licensing Agency Rapid Clearance Service (CLARCS), 90 Tottenham Court Road, London W1P 0LP, UK; phone: +44 (0)20 7631 5555; fax: +44 (0)20 7631 5500. Other countries may have a local reprographic rights agency for payments. Derivative Works Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal circulation within their institutions. Permission of the Publisher is required for resale or distribution outside the institution. Permission of the Publisher is required for all other derivative works, including compilations and translations. Electronic Storage or Usage Permission of the Publisher is required to store or use electronically any material contained in this journal, including any article or part of an article. Except as outlined above, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the Publisher. Address permissions requests to: Elsevier Science Global Rights Department, at the mail, fax and e-mail addresses noted above. Notice No responsibility is assumed by the Publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. Although all advertising material is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer.
The subject of regulation will see divided loyalties amongst our readership. As far as filtration and separation equipment manufacturers are concerned, regulation can offer a welcome boost to sales. The more standards that are applied to the environment and healthcare (dealing with safety for example) or drivers that necessitate optimisation in manufacturing – or greater attention to detail throughout a process – is positive for a filtration company. But as end users of filtration equipment know, regulation can prove both costly and difficult to implement. One industry in particular has had its fair share of regulation. The Life Sciences industry is a vast arena, where filtration and separation technology takes its place among arguably the widest range of processes of all the industrial sectors; ranging from simple chemical syntheses to complex drug production. The industry encompasses everything from pharmaceuticals – drug discovery, isolating and purifying target molecules of interest, through to preclinical and the different phases of scale up; drug delivery and medical products – how the drugs are administered; and of course the biosciences side that covers the laboratory processes. In addition, one could also add fine chemicals processing into this sector, including a whole range of speciality chemicals such as dyes and pigments, agrochemicals, paints, soaps and toiletries, and essential oils. It is, of course, impossible to cover all these areas in one issue, so we have tried to pick some areas that are particularly relevant to the filtration and separation processes within them. Our focus starts on page 20, with a look at high technology filtration in complex laboratory scenarios. We touch on the above regulatory conundrum on page 24, by offering an insight into how small clinical biomanufacturing facilities are finding life with the new clinical trials directive. Our applications this month include a look at how nonwovens and membranes are used within medical devices (page 30), as well as case studies looking at wastewater treatment in a pharmaceutical plant (page 28), and olive oil recovery from process wastewater (page 38). As ever, if we miss anything in our editorial coverage, get in touch. Best wishes
Free circulation enquiries Tower Publishing, Tower House, Sovereign Park, Market Harborough, Leicestershire, LE16 9EF. Filtration & Separation is published monthly by Elsevier Advanced Technology, PO Box 150, Kidlington, Oxford OX5 1AS, UK. The editor will be glad to consider contributions but no responsibility for the safe keeping or return of unsolicited material will be accepted. Filtration & Separation is a member of BPA International, the leading world auditor of business publications. Journal Number: 02127 Printed by: Headley Brothers Ltd, UK.
contact:
P.S This month’s “must reads” – an opinion column from Pall Life Sciences’ president Roberto Perez, and the inaugural Society Roundup column, with Mompei Shirato, president of the Filtration Society Japan Association.
ELSEVIER ADVANCED TECHNOLOGY PO Box 150, Kidlington, Oxford OX5 1AS, UK. Fax: +44 (0)1865 843971 or 843973.
Editor David Hopwood Tel: +44 (0)1865 843642 E-mail: [email protected] Assistant Editor Liz Nickels Tel: +44 (0)1865 843914 E-mail: [email protected]
Advertisement Manager Europe/USA Bart Crabbé Tel: +44 (0) 207 611 4150 E-mail: [email protected] Advertisement Sales Executive (Spain/Far East/UK): Sally Pye Tel: +44 (0) 1865 843081 E-mail: [email protected]
Advertising copy Tel: +44 (0) 1865 843819 Email: [email protected] Production/Design Controller Colin Williams
www.filtsep.com Product Finder Naomi Reeves Tel: +44 (0)1865 843271 Email: [email protected] Managing Director Mark Purvis
1