ASEPTIC SERVICES SPECIALIST INTEREST GROUP by c379altz

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									                ASEPTIC SERVICES SPECIALIST INTEREST GROUP


            MINUTES OF THE MEETING HELD ON 7th SEPTEMBER 2001
             AT STIRLING ROYAL INFIRMARY CONFERENCE CENTRE

Present:       Tom Murray
               Liz Stanley
               Jaqui Sneddon
               John Milne
               Andy Parker
               Richard Williamson
               Christine Alexander (QUASIG Representative)
               Graham Conkie

Apologies:     Brian Jappy
               Simon Bath
               Steve Leadbetter
               Liz Kemp (Aberdeen Royal Infirmary)

1.     MINUTES OF MEETING HELD ON 29th AUGUST 2001

       With reference to point 7 Tom Murray confirmed that pyrogen testing has to
       be carried out by radio pharmacies because the test is not undertaken in
       industry.


2.     ISOLATOR CONFERENCE 28th – 30th OCTOBER.

       John Milne attended the conference and reported back various points for
       discussion:
             - A new version of the yellow book ‘Isolators for Pharmaceutical
                 Applications’ is about to be released
             - Current recommendations are still a background environment of
                 grade ‘D’ for both positive and negative pressure isolators, with
                 appropriate hatch mechanisms.
             - Standards for isolators are all very similar around the world
             - Apparently there is no ‘evidence’ to say that negative pressure
                 isolators should be used exclusively over positive pressure isolators
                 for the reconstitution and manipulation of cytotoxic drugs. The old
                 argument that positive pressure isolators are better at protecting the
                 product from the operator.
             - This lead onto leak testing, if a negative pressure isolator develops
                 a hole in the glove/sleeve system then the hole would produce a
                 fine but powerful jet of air. The jet of air could potentially be injecting
                 particulate and viable contamination directly into the controlled work
                 area.




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               -   Leak testing can be split into two categories (1) leak detection tests
                   and (2) pressure decay tests. Leak detection is very difficult to do,
                   but test methods include filling the isolator with nitrogen and
                   detecting for the presence of oxygen internally, filling with helium
                   and detecting for helium externally or DOP testing. Pressure decay
                   testing is easier to perform but does not identify the hole’s location.
                   Pressure decay testing also becomes complicated with ducting, in
                   this situation a specified closing down procedure must be followed.


3.     REPORT FROM QUASIG

               -   The External Audit tool is to be updated to fall into line with a
                   national audit reporting system. Section headings from Alison
                   Beanie’s book ‘Quality Assurance of Aseptic Preparation Facilities’
                   will provide the structure of audits for all NHS facilities within the UK
                   in an effort to develop a UK database.
               -   There may be a £20,000 - £30,000 allocation of the Scottish Cancer
                   money made available for audit, this could be used to fund the
                   expenses of auditors visiting facilities, and also to help improve the
                   existing audit tool.
               -   Ninewells have developed a contingency plan for their cold store,
                   which involves grouping those items together, in the cold store,
                   which have similar shelf lives at room temperature. (more details
                   from Ninewells)
               -   All drugs are defined as ‘special waste’ and must be returned to
                   pharmacy. From the 1st January 2002 any vial containing residue,
                   or is only part used must be returned to pharmacy and disposed of
                   appropriately. QASIG is to produce a standard, which will be in line
                   with SEPA guidelines due for publication.
               -   The procurement sub-group has been disbanded and a new
                   Pharmacologistics Operations Group (POG) has been formed. The
                   national contract awarding process has been split into 6 therapeutic
                   categories and will require QA input.

4.     SCOTTISH CANCER CARE PHARMACY GROUP

               -   The group is producing a capacity model for the future increase in
                   cancer services. This includes staffing levels aseptic production
                   levels and clinical pharmacy requirements. The capacity model is to
                   be circulated in the New Year.
               -   The group has asked ASSIG to produce a national stability
                   database for cytotoxic drugs; (information obtained by aseptic
                   departments direct from manufacturers which is not contained in the
                   ‘Cytotoxic Handbook’ or the SPC’s). ASSIG members decided that
                   this was a very good idea but is not within ASSIG’s remit. A fully
                   resourced thorough project is required. A list of internet websites
                   were suggested in the interim.
                       www.stmarys.demon.co.uk
                       www.marcguidelines.com
                       www.pallmed.net


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5.     NHS PRODUCTION COMMITTEE

       Graham Conkie reported back on the meeting held 10/10/01
            - Labels for unlicensed medicines will have to have ‘Unlicensed
               Medicine’ printed on their label
            - An MCA consultation letter MLX 275 on labelling and packaging
               has recently been released and is available on the MCA website
            - Expiry dates should be written as ‘Use Before ……… ‘
            - EC directive on clinical trials states that it will become law in 2003
               that clinical trials material must be controlled and released by a QP


6.     NATIONAL CIVAS STRATERGY GROUP

       John Milne reported back on this newly established multidisciplinary team.
       The group consists of representatives from
                           Pharmacy
                           Nursing
                           CEO
                           Prescribers

       Whose remit is to look at taking aseptic services forward.
       Which is to be investigated from various angles
                           Production level
                           Nursing level
                           Dose banding
                           Common prescribing policies
                           Good practice standards
                           National contracts
                           CRAG funding


7.     OPEN MEETINGS DECEMBER 5th AND 12th

       Format:         Registration and coffee                    9.30 – 10.00am
                       Introduction                               10.00 – 10.30am
                       Radio Pharmacy lecture                     10.30 – 11.00am
                       Coffee                                     11.00 – 11.30am
                       Workshop                                   11.30 – 12.15am
                       Workshop                                   12.15 – 1.00pm
                       Hot Buffet                                 1.00 – 2.00pm
                       Workshop                                   2.00 – 2.45pm
                       Workshop                                   2.45 – 3.30pm
                       Plenary session and close                  3.30 – 4.00pm
                       Coffee                                     4.00pm –




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       Workshops will be on,
                  Capacity planning            – John Milne, Donald Coxon
                  Biotechnology                - Liz Stanley, Graham Conkie
                  Audit                        - Christine Alexander, Irene Cooper
                  Validation                   - Baxter Miller

       Cost will be £40 per candidate and application forms from Liz Stanley or
       Graham Conkie.

       Company stands so far include,
                         Posturite                     – stools, chairs etc.
                         Baxter                        - Sterile infusion fluids
                         Schering-Plough               - Infliximab
                         Fresenius-Kabi                - Sterile infusion fluids

8. ASEPTIC DISPENSING PROCESS GUIDELINES

   Deferred until 22/02/02


9. ASSIG AIMS AND OBJECTIVES

   Deferred until 22/02/01


10. AOCB

       Strathclyde University course will run from Tuesday 23rd April 2002 to Friday
       4th May 2002. John Milne is looking for volunteers to help run the course.

       Richard Williamson is to lease with Val Findlay with regard to the aseptic
       checking technician’s course for 2002.

       The new edition of the CIVAS handbook is to come out in the next 6 months.

       Scottish Home Parenteral Nutrition, Managed Clinical Network, meeting will
       be held on 6th December at The Royal College of Surgeons Edinburgh.
       Registration and sandwich from 12.00 noon, close at 4.00pm. Further
       information from Janet Baxter, Endoscopy Unit, Ninewells Hospital, Dundee
       DD1 9SY. Cost is £5.00

       ASSIG dates confirmed for 2002 –
                                       February 27th
                                       May 29th
                                       August 28th
                                       November 27th




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