Webinar- Improving your environmental monitoring process (free to join)

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

EDQM: Microbiological control symposium

A symposium on microbiology in the pharmaceutical sector was the opportunity for the EDQM to gather feedback from users of the European Pharmacopoeia on alternative testing methods for microbiological control and sterilisation processes. The event, which took place in Strasbourg on 10-11 October 2017, was attended by a wide range of experts in the pharmaceutical and microbiological fields who reviewed the latest trends and innovations in the field of microbiology, in addition to Pharmacopoeial approaches and related regulatory requirements.

Over recent years, the European Pharmacopoeia has given pharmaceutical manufacturers access to new chapters for microbiological control, kick-starting a new era for the world of microbiology and rendering the uptake of modern microbiological methods an evolution already in process, rather than a revolution.

Among the topics covered was the use of modern methods for microbiological control, with specific sessions focusing on sterilisation and biological indicators, rapid microbiological methods and control methods for cell therapy products and pharmaceutical water. Reports on successful new methods gave an overview of the potential benefits in terms of costs and time efficiency and, most importantly, in terms of quality. Authorities, manufacturers and suppliers of new technologies also discussed the current acceptance of these new methods at a regulatory level across the world. Over recent years, the European Pharmacopoeia has given pharmaceutical manufacturers access to new chapters for microbiological control, kick-starting a new era for the world of microbiology and rendering the uptake of modern microbiological methods an evolution already in process, rather than a revolution.

Various chapters of the European Pharmacopoeia have laid the foundations for the use of modern methods for microbiological control and have been available for more than ten years – notably 5.1.6. Alternative methods for control of microbiological quality, 2.6.7. Mycoplasmas, 2.6.12. Microbiological examination of non-sterile products: microbial enumeration tests and 2.6.27. Microbiological examination of cell-based preparations. Chapter 5.1.6 in particular was recently further revised to take into full account the latest technological developments and to provide clear guidance for validating alternative microbiological methods.

Best Practices in Keeping Cleanrooms Contamination Free (course)

Pharmig are hosting a one day meeting on cleanrooms and contamination control:

16th February 2017 – Warwickshire (Near Birmingham International Airport)

• Attend and receive FREE Pharmigs latest publication: Guide to Cleanroom Operation & Contamination Control.
• Introduction to cleanrooms – Tim Sandle – Head of Microbiology, BPL
• Cleanroom behaviour and aseptic practices – Laura Guardi – Senior QA Auditor, AstraZeneca
• Selection, specification and qualification of cleanroom clothing – Tim Eaton – Sterile Manufacturing Specialist, AstraZeneca
• Implementing a cleanroom gowning qualification programme – Speaker Invited
• Practical workshop – Led by all speakers
• VDI Guideline 9.2 –The Harmonisation Process within the Pharmaceutical Industry – Carsten Moschner – Chairman 2083- 9.2, VDI Association
• Selection of consumables for cleanroom use (session TBC) – Carsten Moschner – Chairman 2083- 9.2, VDI Association
• Validation of hand hygiene products – Kim Morwood – Director, MGS Laboratories

Tim Sandle is presenting on cleanrooms and contamination control

Download the Agenda and Booking Form

Best Practices in Cleaning & Disinfectants (course)

Pharmig are running a one day course of interest:

15th February 2017 – Warwickshire (Near Birmingham International Airport)

• Attend and receive FREE Pharmigs updated publication: Guide to Disinfectants and their use in the Pharmaceutical Industry.
• Regulatory overview of current disinfection practices and standards – Proposed speaker: MHRA (Invited)
• Cleanroom contamination and need for disinfection – Tim Sandle – Head of Microbiology, BPL
• How disinfectants work – Laura Guardi – Senior QA Auditor, AstraZeneca
• Strategies for disinfectant validation: a practical approach – Kim Morwood – Director, MGS Laboratories
• Key elements for a disinfection policy – Laura Guardi – Senior QA Auditor, AstraZeneca
• Best practice for application of cleaning agents and disinfectants – Karen Rossington – European Marketing Manager, Contec
• Practical workshop demonstrations – All speakers will help to run this session

Tim Sandle is presenting on spores and sporicides. 

Download the Agenda and Booking Form

SfAM Winter Meeting Psychrophilic and Extremophile Microbiology

Microbiology meeting on: Psychrophilic and Extremophile Microbiology, organised by the Society for Applied Microbiology.

19 January 2016
One Great George Street, Westminster, London.

SfAM Winter Meeting Psychrophilic and Extremophile MicrobiologySfAM Winter Meeting 2016 Programme by Tim Sandle

Posted by Dr. Tim Sandle

Free webinar on ISO 14698

ISO 14698: Learn about general principles and methods of biocontamination control in cleanrooms according this ISO norm and also about the validation of an agar plate active microbial air sampler.

The ISO 14698 part of the webinar is led by Dr Tim Sandle

The air-sampler validation part is led by Anne Connors, Field Marketing Manager, Merck Millipore.

The webinar will allow time for questions.

To sign-up for the event, see Merck Millipore.

REGISTER TODAY!

Live webinar on the validation of an agar plate active microbial air sampler according to ISO 14698

Posted by Tim Sandle

Pharmig webinar - Disinfection/Sanitisation Processes

Pharmig webinar - Disinfection/Sanitisation Processes

Join us for a webinar on Jun 25, 2015 at 2:00 PM BST.

Register now!

Led by Dr Tim Sandle - Pharmig Committee Member - The Disinfection/Sanitisation Processes: cGMP for Cleaning and Disinfection webinar will cover the following:

Regulations relating to cleaning and disinfection

• FDA and MHRA points for consideration
• Selection of detergents
• Selection of disinfectants (manual and automated systems)
• How disinfectants kill microorganisms
• Disinfectant rotation
• Disinfectant field trials: what do we want to achieve?
• Orientating the environmental monitoring programme to assess cleanroom cleanliness

The webinar will run for 45mins with 15mins Q&A session at the end

FEES: Pharmig Member £70 sterling / Non Member £100 sterling

Registering:

You can register by clicking on the link above and I will contact you for payment details etc. or through the Pharmig website www.pharmig.org.uk

If you have any questions please do contact the Pharmig office

E: info@pharmig.org.uk T:+44 (0) 1920 871 999

Posted by Tim Sandle

Pharmig webinar - Microbiological Risk of Personnel and Cleanrooms

Microbiological Risk of Personnel and Cleanrooms - 28th May 2015

Join Pharmig for a webinar on May 28, 2015 at 2:00 PM BST.

Register now!

Led by Dr Tim Sandle, Pharmig Committee Member - Microbiological Risk of Personnel and Cleanrooms will cover the following:

• Cleanrooms
• Contamination control risks
• Human microbiome and the ecology of skin
• Protecting cleanrooms
• Monitoring: finger dabs and gowns
• Alert and action levels
• Characterising microflora

The webinar will run for 45mins with 15mins Q&A session at the end

FEES: Pharmig Member £70 sterling / Non Member £100 sterling

Registering:

You can register by clicking on the link above and I will contact you for payment details etc. or through the Pharmig website www.pharmig.org.uk

If you have any questions please do contact the Pharmig office

E: info@pharmig.org.uk T:+44 (0) 1920 871 999

Posted by Tim Sandle

Sterilisation, Sanitisation and Disinfection course

New PHSS course: Sterilisation, Sanitisation and Disinfection

Requirements of effective contamination control and the appropriate steps to manage deviations.

• DATE: Thursday 18th February 2015
• VENUE: Four Pillars Hotel, Abingdon, U.K.
• PRICE: £350 Members, £450 Non Members

Speakers:

Jenni Tranter, Synergy Health
Alan Heavey, Sterilisation Solutions Ltd
Tim Sandle, BPL
Alison Livsey, Contec

For details see: PHSS course

Posted by Tim Sandle

Risk based environmental monitoring webinar

Stay current with industry best practices for Environmental  Monitoring. Join us for an educational webinar on how  to implement a Risk-Based approach with your current Environmental Program.  

Topics covered include:

• Proven risk assessment techniques designed to develop or simply fine-tune your EM program.
• How the use of environmental monitoring software improves your program through continuous monitoring ensuring a state of control.
• Actual case studies that illustrate examples of key concepts.
• How to achieve Lean Manufacturing through the use of such techniques.

Speakers:

Dr. Tim Sandle, Experienced Microbiologist, Quality Professional, Auditor & Technical Writer

Ilona Endisch , Associate Director of Product Innovation at Novatek International

Registrations will open in January 2015, however please  reserve your place today. We look forward to having you join us at this event!

Event organized by Novatek International:

www.ntint.com

To register, go to Novatek.

Posted by Tim Sandle

Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector

Pharmig presents:

Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector

Tuesday 28^th October 2014

Best Western Plus Windmill Village Hotel, Golf & Spa, Coventry

09.00 – 09.30                       Registration with tea/coffee

09.30 – 09.45                       Chairs introduction
                                                Dr. Tim Sandle – BPL and Pharmig Committee Member

09.45 – 10.30                       Microbiological regulatory aspects of garments and gloves

                                                Speaker: Greg Cochran – Micronclean

10.30 – 11.15                       Microbiological risk to cleanrooms and disinfection

-          Cleanrooms

-          Contamination and contamination sources

-          Selecting detergents and disinfectants

                                                Speaker: Dr. Tim Sandle – BPL & Pharmig Committee Member

11.15 – 11.45                       Morning break with tea/coffee

11.45 – 12.30                       Cleanroom garments for effective ongoing contamination control
                                                -      Personnel contamination and Regulatory Authority requirements

-          Requirements for effective cleanroom garments and assessment for garment lifetime

-          Gowning procedures and validation

-          Garments and cleanroom energy considerations

                                                Speaker: Tim Eaton – AstraZeneca

12.30 – 13.30                       Lunch

13.30 – 14.15                       Gloves and standards

-          What are the ideal properties of gloves for aseptic properties

-          Weaknesses of gloves

-          Use of gloves in isolators

-          Comparisons between American and European standards

-          Chemical and microbiological testing

-          Cytotoxic testing

-          Practical approach to gloves and standards

                Speaker: Mark Oldcorne – Wrexham Maelor Hospital

14.15 – 15.00                       Validation and Application of Hand Hygiene Products

                Speaker: Laura Guardi – ECOLAB

15.00 – 15.20                       Afternoon break with tea/coffee

15.20 – 16.00                       Q&A with the Expert Speaker Panel & Conducting a Cleanroom Clothing Survey
                                                This session will be dedicated to delegates where they can ask speakers additional                                                                                questions relating to Cleanroom Clothing issues.                                          

                                                We also ask that within this session you kindly take the time to complete a questionnaire                                                    on Cleanroom Clothing –the aim of which is to look to produce a ‘Best Practice and Issues                                                   around Cleanroom Clothing in the Healthcare and Pharmaceutical Sectors’ as an article                                                                     and/ or publication

16.00 – 16.15                       Chair’s closing remarks

For details contact Pharmig

Posted by Tim Sandle

ECA events

The ECA are running two events of interest:

1. PharmaLab 2014, including the Endotoxin and Pyrogen testing Conference, on, 19/20 November 2014 in Neuss/Düsseldorf, Germany –www.phamalab-congress.com

2. RMM Conference and Mycoplasma Testing Conference fro 09-11 December, Heidelberg, Germany www.rmm-conference.org

The European Compliance Academy (ECA) was founded on the 1st of January 1999 as an independent membership association and is today the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. Close to 4.000 members from all over Europe and abroad represent more than 60 countries.

Posted by Tim Sandle

Leading pharmacists debate hospital infections

This week the leading pharmacists in the U.K. congregated in Warwick for the NHS QA Symposium. A number of measures to protect patients from infection were discussed, and Digital Journal was in attendance.

Most of the U.K.’s health provision is delivered through the National Health Service (NHS). Among the care provided is the manufacture of small batches of medicines through specialist pharmacy units. Those involved in this process include technicians, medics, pharmacists and microbiologists. The main principle by which the medicines are produced is Quality assurance (QA).

Once a year, managers, specialists and scientists gather to discuss the latest technologies and best practices at the QA Symposium.

One of the running themes was about making error free medicines. A session on this subject was led by Professor Anna Guha, from Royal Liverpool and Broadgreen University Hospitals NHS Trust. The talk focused on getting procedures right and understanding different learning styles. Control and procedures featured in several talks, including the appropriate design of software. One presentation by Peter Rhodes looked at the ideal software for hospital compounding.

A lively debate took place about “vial sharing”. This is whether a vial of drug should be single-use or shared between patients. Although most drugs come in single-dose vials (SDVs) they typically contain more drug than one dose. On this basis, can the same vial be used for more than one patient? The argument for vial sharing is in relation to cost savings. The argument against centered on risks to patient safety, especially the risk of contracting a hospital acquire infection. The issue that everyone seemed to agree on is that the “leftovers” from two different vials should not be pooled together, mixed, and then administered to a patient.

In a presentation on pharmaceutical microbiology, Dr. Tim Sandle discussed the need to find out exactly what types of microorganisms are present in the environment and then to apply this knowledge to select the best disinfectants and biocides that can kill these microorganisms so they do not remain in the areas where medicines are prepared. Following this, Nicola Swift explained why characterizing microorganisms was important: “accurate identification is of great importance”, she explained, before outlining some advances in rapid and more accurate methods.

In a related area, there were several stands and posters providing information about hospital acquired infections. Here a strong emphasis was placed on healthcare professionals washing their hands and using effective hand sanitizers, as a means to lower the risk of infection to patients.

The thorny issue of outsourcing was brought to the table by pharmacist Richard Bateman. This relates to the issue of the extent that health provision in the U.K. is subject to privatisation. Bateman’s presentation was focused on maintaining quality standards. Talking to many of the delegates, the vast majority who expressed an opinion were concerned about privatization of the health service, especially with outside companies coming in and having lower quality standards.

Overall the conference raised and debated a number of contemporary and important issues relating to healthcare and the preparation of medicines.

Posted by Tim Sandle

NHS Pharmaceutical QA Service Annual Symposium, 16th-17th September 2014

Organised by the NHS Pharmaceutical Quality Assurance Committee, the annual event brings together key pharmaceutical staff from across the UK. The 2014 programme offers a variety of presentations and workshops to educate and update delegates on current issues within the pharmacy industry, with a focus on "Optimising Patient Care Safely".

The event is taking place at Chesford Grange Hotel, Kenilworth on 16th – 17th September 2014.

For further details see: NHS QA

Posted by Tim Sandle

Webinar on Media Fill Trials for Aseptic Process Control in Sterile Pharmaceutical Manufacture

Register Today: You’re Invited to an Exclusive Webinar on Media Fill Trials for Aseptic Process Control in Sterile Pharmaceutical Manufacture Together, Cleanroom Technology and Thermo Fisher Scientific present A Risk Matrix Approach for Media Simulation Trials in Sterile Pharmaceutical Manufacture. In this exclusive webinar, we’ll explore important factors to consider when designing a media simulation trial program, and examine how these factors can be used to establish a risk-based matrix. You will also learn how single-use technology can aid safe and simple validation of aseptic manufacturing processes. Presenters: Tim Sandle PhD – Head of Microbiology, Bio Products Laboratory Ltd (BPL) Colin Booth – Global Director of Quality Assurance and Regulatory Affairs, Microbiology, Thermo Fisher Scientific Time: 9:00am CST, 3:00pm BST, 4:00PM CET Date: September 24, 2014 This is a Thermo Scientific marketing and promotional message. Please review our Privacy Policy. 81 Wyman Street Waltham, MA 02451 USA © Thermo Fisher Scientific Inc. All Rights Reserved. Want to unsubscribe or change your details? Minimize Close     0

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The Rapid Microbiology Lab: Applying New Technologies to Traditional Methods

“The Rapid Microbiology Lab: Applying New Technologies to Traditional Methods” and includes speakers from our company, Lonza and Charles River.

The event is from 10am to 5pm at the Plum Park Hotel (Watling Street, Towcester, Northants NN12 6LG) and includes lunch.

Agenda

1000 – Arrival, coffee, Tea, Pastries

1015 – Introductions

1030 – The Rapid Microbiology Lab, the role of automation and technology

1100 – Automating the Incubation, Detection, and Enumeration steps without changing sample preparation

1130 – Applying Automation to Sterility Testing

1200 – Lunch

1300 – Applying automation to Environmental Monitoring and Bioburden testing

1345 – The role of technology in Microbial ID

1445 – Creating the paperless lab

1545 – Break

1600 – Validation of automated technologies

1630 – The Importance of Support

1700 – Final Q&A, Departure

For details, see: RapidMicroBio

Posted by Tim Sandle

Fungal Contamination in Pharmaceutical Products and Cleanroom Risk (webinar)

Dr Tim Sandle (Pharmig Committee Member) will present a one hour lecture on Fungal Contamination in Pharmaceutical Products and Cleanroom Risks (including a Q&A section) on Wednesday 19th February at 2pm (GMT).

The session will cover:

• Review of fungal contamination recalls 
• Types of fungi isolated 
• Cleanroom and operator contamination sources 
• Implications: environmental monitoring, disinfectant testing and media QC 

FEES: Pharmig Member £70 sterling / Non Member £100 sterling

Payment can be made by credit card via www.pharmig.org. uk and clicking on meetings and Fungal Webinar.

Or, you can email the Pharmig office who will contact you for card details info@pharmig.org.uk

Or, by raising a purchase order (this needs to be sent to the Pharmig office before the start of the webinar)

If you have any questions please call Pharmig on +44 (0) 1920 871 999 / email: info@pharmig.org.uk

After registering, you will receive a confirmation email containing information about joining the webinar.

View System Requirements
Posted by Tim Sandle

Pathogen Safety Summit

Pharmaceutical Microbiology is pleased to be a media partner with the 2013 Pathogen Safety Summit.

The theme this year is 'Ensuring quality in raw materials, new technology use and data presentation'. The details are:

Focusing on advanced heuristics to contain known and emerging pathogens quickly and effectively, key topics covered this year include:

• Deep sequencing for quality and in-process control testing
• Single-use virus nanofiltration systems in downstream processing
• Regulatory guidance on ensuring the safe provision of raw materials
• Sterile manufacturing for advanced therapy medicinal products including cell and gene therapies
• Responding to mycoplasma, virus, prion and bacterial contamination
• Techniques to remove and inactivate pathogens without degrading raw materials
• Formatting data from massively parallel sequencing for regulatory approval

Following the success of last year’s crisis management session, this year’s meeting again enables you to calmly pool, apply and receive feedback on what to do when contamination is reported. In addition, round-table discussions and workshops distil the essentials of identifying, understanding and responding to in silico, in vitro and in situ results.

Join us in Munich to apply lessons learned by regulators, industry experts and academic representatives on avoiding, detecting and removing contamination.

Posted by Tim Sandle

NHS QA Symposium for Technical Services (September 2013)

Details of an important course for those working in healthcare or quality assurance:

NHS Pharmaceutical Quality Assurance Committee

This annual event is aimed at pharmacy professionals, including technicians and pharmacists, working in pharmaceutical production and quality assurance environments. The symposium is aimed at both the NHS and commercial sectors.

The format encourages delegates to structure their own experience of the event around their individual needs and interests with a range of lead presentations, workshops and commercial presentations. The social aspect on the evening of day one allows opportunity for further discussion and networking. The exhibition provides a great opportunity to speak to pharmaceutical companies and equipment suppliers. All the companies you need to develop your service in one place.

Tuesday 24th – Wednesday 25th September 2013

The Crowne Plaza, Chester, UK.

For details, see the course brochure.

Posted by Tim Sandle

PDA 8th Annual Global Conference on Pharmaceutical Microbiology

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpufPDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology - See more at: http://www.pda.org/microbiology2013#sthash.Im1svIcB.dpuf

PDA 8th Annual Global Conference on Pharmaceutical Microbiology

This annual conference is dedicated to advancing science and regulation for global pharmaceutical microbiology by introducing the best practices of today and innovations of tomorrow.

The PDA 8th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies.

For further details, see the refer to the course brochure. 

Posted by Tim Sandle