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Dr. Rachel Gill

EU GMP Annex 1: Take 2 – what is new for cleaning and disinfection?

Annex 1: Overview from Redditch Medical’s James Tucker

After the last revision of Annex 1 as a draft was issued for consultation in December 2017, there have been many changes to the world in which we live. The EMA left its London premises on the first of March 2018, relocating to Amsterdam in response to the UK decision to leave the EU (Brexit).  Now, across the globe we are influenced in our daily lives from the impact of the global COVID pandemic: from lock downs to supply chain or occupational issues or even on a more personal level.

The UK decision to leave the UK drove to the French competent authority to take up the mantel of updating Annex 1 and the significant work that had been undertaken to bring the guideline up to date. However, even this work is not immune to the effects of COVID 19 with the consultation open period being extended to June 2020. So, for those expecting this to be implemented some time ago I am afraid there is still a way to go, but, perhaps this allows us time to consider the intent and prepare for the expectation of inspectors.

There are some significant changes in this latest incarnation of the Annex, not least in the Opening scope where QRM (Quality Risk Management) and its implementation throughout is called out, even when not specifically referenced. The scope also covers the decision of the manufacture to elect the application of the guidance for products not intended to be sterile, but which benefit from the control / reduction of microbial, particulate and pyrogen contamination. 

The CCS (contamination control strategy) has gained additional strength and continues include the requirement for cleaning and disinfection as part of the collective contamination control measures, including continuous improvement.

Transfer disinfection continues to make a prominent feature as part of cleaning and disinfection, reiterating the need for an approved list of items for transfer into Grade A or B zones, as well as the need to protect items through the transit of Grade B. Any items not approved, should be transferred through on pre-approved exceptions, and risk mitigation measures for this should form part of the CCS. It continues to re-iterate the need for transfer from lower grade (previously not mentioned) or unclassified areas to higher grade cleanrooms should be subject to cleaning and disinfection commensurate with risk – it would therefore be my understand that as Bioburden is higher in low grade areas the use of a sporicidal would be prudent – this would have to measure against the risk of re-introduction at a later stage of the material transfer process as well as residues from the disinfectant, when using non/weak sporicidal products with no/minimal residue at later stages.

Under the specific section on disinfection the Annex still includes a focus on the requirement for residue management and this is now no longer in brackets which may indicate an increased authority for this element. The sentence on residue removal does now however, no longer include the word first which would indicate that in line with the increased emphasis on QRM, that the prior cleaning could be managed. It is also important in this section to note that more than one agent should be used with different modes of action to control bacterial and fungal contamination – this would indicate that the expectation is that broad spectrum disinfectants are expected to provide the users with regular fungicidal control – which not all broad spectrum products do today.  Sporicidal products are separated as a period control measure. The section also now includes the requirement of monitoring for resistant organisms, which could be especially problematic when products do not provide fungicidal efficacy as mentioned previously.  

It emphasis the need for end users to validate the disinfectant in the way they are actually used and for the period of use (e.g. contact time). Where products are made up in house there is an increased burden on proof of monitoring and in-use shelf life, whereas products supplied “ready-made” are subject to the control measures in place for the vendor.

I am sure this will continue to be debated, perhaps more via zoom and other platforms than in the usual forums. However, I am also sure we will continue the general intention of this and the previous draft to Annex 1 and I look forward to seeing the final incarnation of the annex after the long anticipation.   

The Right Place at the Right Time!

As a UK busness, Redditch Medical has expanded our operation to supply hand sanitiser to the NHS and customers around the world.

Our new development has created six new jobs at Heming Road site to produce Inspec HG, a alcohol hand sanitiser, which was created by the firm’s Midlands operation in just four weeks!!

https://lb.worcesternews.co.uk/news/regional/18434538.redditch-company-entaco-expands-supply-sanitiser-nhs/?ref=rss

InSpec Hand Sanitisers

Redditch Medical has launched its hand hygiene range in a time of greatest need. As the Coronavirus pandemic continues to effect daily life with an imminent release from "lock down" expected and an expected increase in PPE and Infection Prevention required Reddtich Medial is prepared to support.

With two formulations in the range a hand rub (InSpec HR) and a hand gel (InSpec HG). The hand rub is manufactured according to the World Health Organisation formual and is available in a convenient personal spray bottle. The Hand Gel is specially formulated to provide fully viricidal efficacy and excellent skin compatibility with provitamin B5, aloe vera and glycerol designed to protect the skin during use. http://www.redditchmedical.com/downloads/Redditch-GelRub.pdf

With the development of this new range Redditch Medical has added further investment into the InSpec brand with new premises and filling lines.

Hand Hygiene – hand in hand with helping the local community

During the development of our new InSpec HG, we were informed of a requirement of the local Fire Service.   In these unprecedented times, the emergency services are doing an incredible job to keep us all safe whilst putting themselves at risk.  It was therefore an easy decision for Entaco/Redditch Medical to donate the first bottles of our new Hand Gel to our Fire Service, keeping us and them safe.

Giving something back

Our Company is proud to be able to support the NHS at a time when they need it most.  We have donated InSpec Alcohol wipes to each of our existing NHS customers to help protect our vital front-line hero’s during the current pandemic.  This includes our local hospitals and trusts, Sunderland, North Tees and North Tyneside.

“I just wanted to say a big thank you for the IPA wipes, they were much appreciated.”

"We have received our supply of single wipes this afternoon and have already distributed them to the Pharmacies and Dispensaries throughout the Trust.  Can you pass on our thanks to all at Redditch Medical"

New Dates: Cleanroom Technology Conference

Join the Redditch Medical team at our booth at the Cleanroom Technology Conference, Birmingham, UK, on the 28th and 29th October 2020, where, James Tucker will be speaking about the Holistic Approach to Cleanroom Contamination Control.

For more information please contact info@redditchemdical.com

Register at https://cleanroomtechnology.com/news/article_page/Registration_now_open_for_Cleanroom_Technology_Conference_2020/161025

Lounges 2020

Redditch Medical were please to join our Distributor, IAB, at the Lounges exhibition in held Karlsruhe, Germany on the 28-30 January 2020.

James Tucker, Sales and Marketing Director, took part in talks about the InSpec range, the latest requirements of Annex 1 and its impact on Cleanroom Contamination Control.

Award Winning

James Tucker, sales and marketing director has been announced as the winner of the John Sharp Memorial Award 2019! with the scientific paper entitled “The proposed changes to Annex 1: Considerations for the cleaning and disinfection processes.”
Author: James Tucker

The paper was published in the Society’s Journal, The European Journal of Parenteral and Pharmaceutical Sciences 2019 Volume 23 Issue 4. This award is given each year to the best paper published in the four issues of the journal over the period of one year. The votes are cast by the PHSS Members.

Redditch Medical Increases Operational Footprint

To effectively manage the fast-growing demand of the preferred choice InSpec range, Redditch Medical have increased the operational footprint adding further warehouse capacity and a Laboratory.

Two new warehouses have been added, allowing our organisation to grow comfortably when considering the expected demand over the coming years.  The new facility provides the opportunity to reorganise the layout to optmise efficiency whilst maintaining the segregation expected by GMP.

The laboratory is seen as an important step in the development of Redditch Medical.  The lab will be used to control many of the day-to-day verification tests that are required for our WFI quality water and environmental monitoring, but most importantly our new generation of disinfectants and packaging innovations that are currently under development.

The development continues to demonstrate Redditch Medical’s commitment to providing a best in class product and service.

James Tucker Appointment

In late-August 2019 James Tucker, Sales & Marketing Director, joined Redditch Medical (as an Entaco Ltd. Board member), to further strengthen the top management team.  James is considered an expert and recognised name within the Cleanroom Contamination Industry with over 15 years’ experience working in contamination control, advising a global customer base of all the major pharmaceutical and medical device manufactures.  James sits and has sat on several industry committees inc. PDA (UK chapter board member), InterPhex (technical committee advisor), Pharmig (former committee member), CEN TC 216 working group (inc BSI member).

“ I am excited to be joining such a dynamic, customer focused and forward thinking organisation who are taking the marketplace by storm” says Tucker.

SYSPRO 8 depolyed at Entaco Ltd & Redditch Medical

Redditch-based medical device and disinfectant manufacturer, Entaco and Redditch Medical has selected K3 Syspro to transform the business through the power of ERP. The manufacturer has enjoyed strong growth in recent years, leading them to upgrade their legacy system to fulfil their potential.  Operations Director Stephen Brown believes SYSPRO ERP will take the business to another level.

Since 1932, Entaco has manufactured components for the specialist needles and medical device. The business has gained a reputation for providing innovative solutions to its customers through an ever-evolving product portfolio, including InSpec disinfectants. However, its IT system failed to keep pace with the demands put upon it and the manufacturer felt the time was right to invest in a comprehensive ERP solution.

Entaco’s new ERP system will be fully implemented within the next four months, transforming the working lives of the manufacturers 136 staff. “Suddenly, we’ll be able to track jobs, control production, monitor costs and view accounts whenever and wherever we please”, says Brown. “That will make us more efficient, productive and able to make informed decisions.”

QT+ Low Residue AND fully Fungicidal

QT+ is the newest addition to the continuing developing InSpec Range.  QT+ has been designed with efficacy and residue management in mind.  As the primary reason for disinfection use is efficacy it was important that QT + delivered fungicidal efficacy, unlike many QAC disinfectants, QT+ is effective against Fungi According to EN 1650 and EN 13697. minimize the risk to our customers on a daily basis. However, it was essential in the development process that other critical factors were also part of the product and therefore not only does QT+ deliver on the efficacy but also has a significantly lower QAC residue than its QT predecessor.

For further information about QT+ please contact info@redditchemdical.com

APPROVAL OF InSpec IPA

APPROVAL OF InSpec IPA – June 2019

Authorisation of Disinfectants to the Biocidal Products Regulation (BPR EU 528/2012)

The BPR is the legislation concerning the authorisation of biocides for use in the European Union (EU). It is Redditch Medical’s intention to ensure all InSpec biocides comply with the BPR and as a provider to such a critical marketplace we are fully committed to supporting all our products through this process.  This enables continued supply of InSpec™ Contamination Control range for use in Biopharma and Medical Device industries. Specifically, this covers Annex V, Main Group 1 Disinfectants, Pt2 Disinfectants and algaecides not intended for direct application to humans or animals.

Redditch Medical is pleased to be one off of the first disinfectant manufacturers to have IPA family authorisation granted according to Regulation 528/2012 of the European Parliament, Product Type 2.   InSpec IPA is approved for sale and for use as a biocidal product according to this product use authorisation.

Redditch Medical’s experience in registration processes has paid dividends in the process as an experienced high quality manufacturer regulated by numerous bodies.

Redditch Medical is now in receipt of the Product Authorisation Certificate from the UK Health and Safety Executive (HSE), Authorisation Number UK-2019-1197, R4BP3 Asset Reference Number UK-0016657-0000 Document Number 2019/92263. 

Redditch Medical Manufacturing Facility Investment

During 2019 Redditch Medical commissioned the construction of two new production cleanrooms and the associated production equipment to support the growth of the InSpec Cleanroom contamination control division.  These cleanrooms have since been validated and commissioned for producing InSpec.

Redditch Medical has optimised this investment opportunity, building a dedicated ISO 5 production suite where all production operations take place. 

Redditch Medical identified this opportunity to upgrade the existing production facilities over 12 months ago and add further storage space, preparation areas, laboratory facilities and resource from the Pharmaceutical Industry.  After diligently reviewing our current customer needs, Redditch Medical considered that further investment was essential demonstrating our commitment to GMP and the needs of InSpec customers. 

Steve Brown commented:  Our new facilities give Redditch Medical ample capacity to continue to support our existing customers in the future.  Furthermore, we have taken a lot time to listen to our customers and expert opinions to build facilities that are the best in the cleanroom contamination control industry. InSpec disinfectants are a critical element in our customer’s production process.  This new production line show the level of care and effort we wish to invest into our customer experience and products supporting InSpec as the brand of choice.

New 100 M2 ISO 6 Cleanroom Sedgefield.

An additional 100 M2 ISO 6 cleanroom is added at the Sedgefield site & commissioned.

This has additional ISO 5 areas within.

InTact product range launched.

Redditch Medical undertook a programme of development over a year ago to formulate test and qualify the InTact range of GMP detergent cleaning systems.

InTact is designed exclusively for use in highly regulated GMP industry applications of clean-in-place (CIP) and Clean-out-of-Place (COP). The InTact range is a unique low foaming, low residue, concentrated detergent formulation based on the latest generation of low toxicity, biodegradable surfactants and chelants.

InTact products are further supported via:

• Pre-qualified analytical test methods are available - TOC and ICP-MS
• A detailed toxicology & formulation profile – releasable to end-users
• The InTact Optimisation service - A laboratory-based service in which stainless steel or glass coupons representing an end-users actual drug & excipient soiling are tested in our laboratory to determine which cleaning agent should be used and at what concentration, time & temperature whilst mimicking cleaning process conditions Three versions on InTact exist:
• InTact Acid – based on Phosphoric acid, surfactants and sequestrant
• InTact Alkaline - based on Potassium hydroxide, surfactants and sequestrant
• InTact Neutral Booster - based on non-ionic surfactants and sequestrant

Redditch develops and launches InSpec N7

A pH neutral detergent product with low toxicology profile.
Available RTU in 5L and 1L trigger sprays also as a concentrated product.
Sterile and Non-sterile.