An hour’s drive from Bengaluru brings me to what looks like a sophisticated pharma manufacturing facility. Professionally controlled delivery vehicles line up alongside the state-of-the-art, access-controlled building. Even the office corridors are immaculately clean. On my way to the conference room, I pass the laboratory of the facility…which doesn’t manufacture anything at all.
Almost one-and-a-half centuries ago, Micronclean started in the UK as a wicker basket-based laundry service for hotels that were springing up because of the arrival of the railways, bringing holidaymakers to the seaside town of Skegness. Today, it is a pioneer in industrial workwear rental, with its first clean room laundry outside of the UK ready and running near Bengaluru – the ‘manufacturing facility’ where I am.
Visitors like me find the strictly controlled environment of the clean room and other areas so far ahead of its time that a pharma business leader – who shall remain unnamed – jokingly suggested that the facility is fit not just for cleaning and disinfecting the uniforms of pharma manufacturing operators, but actually manufacturing drugs as well!
Inspecting for wear and tear
The facility
Commercially operational since 2021, Phase 1 of the Class ISO Class 5 , GMP Grade B cleanroom laundry occupies 4,000sqm of a 12,000sqm plot, with a capacity to process 80,000 garments per week. There is space for Phase 2 right alongside.
Rooftop solar panels meet around half the power requirements. Sensor-activated lighting in various areas, AHU setback nodes and variable frequency drives help save electricity by using only as much as is needed. An innovative heat exchange mechanism between waste process water and input water systems reduces heating requirements, but wait! There is no wastewater; a zero liquid discharge plant and not one but two RO systems recover up to 90% for reuse in the laundry cycle.
That the temperature and humidity are continually controlled needs no mention; 0.3 micron HEPA filters maintain the indoor air quality to exacting standards.
All this must have necessitated significant investments. “We want to be a part of India’s growth story”, said Andrew Cole, Managing Director, Micronclean India Pvt Ltd. “Pharma manufacturing in India remains personnel-based and is riding the surge of the export market; we see tremendous potential for growth.”
Inside the clean room laundry
The model
From the procurement of fabric for new garments, through the collection of used uniforms to the delivery of laundered, sterilised and packaged uniforms to the client, Micronclean handles everything. Each garment is checked, washed, dried, inspected, folded, packed, sterilised, sorted and released for despatch to the client’s facility – which could be as far away as Visakhapatnam or Goa – where a Micronclean associate even places the garment bags in the correct locker.
All garments are the property of Micronclean; no other garments are processed at the clean room laundry.
The stores
All new garments begin their journey at the stores; after donning a coat, hairnet and shoe covers, so do I. This is where various cleanroom garments like coats, gowns and hoods are kept after initial procurement; once issued, they never return here.
Each item is fashioned according to the measurements of the intended wearer. “We emphasise on a good fit at the neck, wrists, ankles and face to reduce particle loss from these openings. Poorly designed gowns or oversized hoods can place an entire pharma facility at risk”, said Cole.
The fabrics from which garments are crafted are chosen according to the part of the pharma facility where the operator will be stationed. Apart from preventing loss of particles from the wearer, it must also not shed particles itself. Control of electro-static discharge from the fabric is another key element.
A heat transfer machine in the stores prints a badge on each garment, with details like company name, contract, wearer ID, department, size, locker number, installation date and other details. This is for visual information; embedded behind this is an RFID tag coded with the same data, which is scanned at every point in the laundry cycle. Both the fabric and the RFID tag are validated to withstand over 100 processing cycles; the system will automatically raise an alert for replacement at this point.
Sorting of laundered, sterilised garments
Sorting & inspection
Upon arrival, used garments are sorted according to type, colour, client etc. Each garment is RFID-scanned, then placed on a light table to look for wear and tear. Let’s say a zipper is found broken; in front of the employee is a screen with an image of the scanned garment…all he or she has to do is select the type of problem and where it is located, before transferring it to the repair trolley.
Scanning one garment after another also enables the process to be automatically stopped when the batch size is reached; the RFID tag also indicates which wash program must be used for each batch. No room for overloading, no room for manual error.
Washing & drying
The trolleys with sorted garments are wheeled to the entry door of a barrier washer-extractor. Once the wash process begins, scores of parameters like wash temperature, process time and water conductivity are controlled and monitored.
A SCADA (supervisory control and data acquisition) system is used to achieve this. For example, it can adjust the drying process time according to the moisture content of each load.
Alarm states are set for all critical stages; failure to meet the specified parameter will result in an immediate alarm and automatic process halt. This way, parametric batch release is achieved.
The used garments are loaded into the washer from a non-clean room environment by employees in blue T-shirts and tan pants; decontaminated garments are taken out into a clean-room environment by employees in full clean room attire, scanned again and loaded into the cleanroom dryer.
Folding and packaging
Folding, packaging & sterilisation
After drying, garments are inspected once again over a light table and folded according to specifications. Each garment is placed in primary packaging made of a breathable material, and transferred to a small conveyor belt which moves it down the line for sealing (with details of date of decontamination, expiration date etc). A trolley full of these is then sterilised by autoclaving (hence the breathable material).
Second sorting
The sterilised packages are retrieved and placed in secondary packing. Each package is then scanned for sorting as per department, operator, colour, item, locker number or any desired classification. All the employee has to do is place it on the shelf indicated by a light that is activated by the scan. Once again, no room for error.
Clean room barriers
The entry and exit doors of the barrier washer-extractor cannot be opened simultaneously. Packaged garments are sent out of the clean room area though an air-lock pass-through hatch.
Inside the laboratory
Positive pressure is maintained in the clean room.
“We use our own cleaning consumables and manpower for maintaining the clean room environment”, revealed Cole. “Nothing is outsourced; to maintain standards, we do it all ourselves”.
Despatch
Garments in secondary packaging are then placed in bags (tertiary bags) that are ready for despatch through delivery vehicles waiting at nearby bays. The sterilisation of these sealed garments is validated for a period of one year.
About time!
Why are clean room laundries set to take off? Sample point 7.17 of Volume 4 of EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use:
‘Reusable clean area clothing should be cleaned in a laundry facility adequately segregated from production operations, using a qualified process ensuring that the clothing is not damaged and/or contaminated by fibres or particles during the repeated laundry process. Laundry facilities used should not introduce risk of contamination or cross-contamination. The garment management processes should be evaluated and determined as part of the garment qualification programme and should include a maximum number of laundry and sterilisation cycles’.
Before the end of this year, these guidelines will be mandatory for Indian pharma companies exporting their products to the European market. Clean room laundering of pharma uniforms, which was good-to-have until now, will become a must-have. And Micronclean – with its ready capacity and technical expertise – is perfectly poised to fulfil this demand.
– Reported by Mrigank Warrier, Associate Editor, Clean India Journal