The thought of using a garment once and throwing it away may seem like an expensive option for your cleanroom operations, but do you know the risks of using launderable garments within your critical processes?
In an ISO Class 5 pharmaceutical cleanroom, the average usage is four garments per day per person, but the protocol dictates that changes must be made each time the cleanroom is re-entered.1 In contrast, a worker in an ISO Class 8 cleanroom might change garments once or twice per week.
With this in mind, the decision to use reusable garments may appear to be more cost effective, but in the long run they could cost you time and money. Launderable garments carry with them many hidden costs and risks.
The cost variables associated with reusable garments in addition to the internal cost of effectively managing a reusable garment system and the weekly rental fee, such as laundering, sterilization, repair of garments, replacement of lost or ruined garments, barcode charges, fuel surcharges, and additional unplanned garment usage charges may be included in your contracted cost.
The laundering process for reusable cleanroom garments involves multiple processing steps such as sorting, multiple wash cycles, drying, cool down, and inspection, all of which will put the fabric under additional stress. This is repeated each time the gown is serviced; therefore the laundering process itself can create channels for bacteria to penetrate the fabric. Product degradation is a very real concern to your mission critical environments.
Impact of repeated laundering and sterilization
Reusable solutions are subjected to cycles of repeated laundering and sterilization. Are their performance garments the same for every cycle? To aid in garment decision-making, Dupont, a supplier of single-use cleanroom garments and accessories, conducted a study to map the properties of polyester reusable garments typically worn in cleanrooms, including information about how properties of these garments can vary after multiple cycles of laundering and exposure to gamma radiation. The study measured such performance measurements as fabric barrier properties (including bacterial filtration efficiency), resistance to breaking and tear, and garment cleanliness and particle generation. The study, along with other research results, shows that reusable garments are vulnerable to damage from laundering and sterilization methods. Changes in garment performance can increase the probability of a contamination incident, and cause damage to sensitive products and processes. Evidence of this damage and changes in performance often is invisible to the naked eye. Visual inspection of the garments is only the first step of the validation process and may not be sufficient to decide on the end of life of the garment.
Protect your brand — avoid the risk of cross contamination
Can you be sure your laundered garments are sterile and that all your stipulations are being honored? Would you be able to provide auditors the data they require on your garments?
Don’t be tied into a contract — avoid balloon payments and the risk of cross contamination by switching to disposable apparel for your critical controlled environments.
According to PDA.org, 30 percent of all microbial detection in sterile cleanrooms is from the gowns. To ensure that your critical environment is protected, it is essential to use the most reliable cleanroom garments. The risks of contamination are too great.
Following garment testing by Kimberly-Clark, it was identified that the Bacterial Filtration Efficiency (BFE) declines more than 25 percent after an average of five washes. That’s the equivalent of one out of four workers not wearing sterile garments at all. This presents a real yet invisible contamination risk to your cleanroom environment.
Single use disposable garments offer increased choice, guarantee optimal performance, and consistency to ensure that the highest levels of sterility are being met and help to reduce the risk of downtime on your processes. They have the advantage that uncontaminated virgin material with proven and documented barrier protection are provided for each use. They also offer greater comfort and breathability, as well as flexibility in sizes to suit operator turnover, changes in size (e.g. pregnancy), and visitor and service personnel.
For lab technicians and others who need to maintain clean or sterile environments and require protection from contaminants, there is a serious risk of introducing harmful matter into new environments if the clothing is taken out of the facility.
Risk vs. waste — what’s more important?
A report by PDA.org states that €2 million per year (about $2.4 million USD) is spent by the pharmaceutical industry in addressing clothing contamination.
Over 50 percent of contamination within a cleanroom is caused by operator error in donning. How the garment is packed following being laundered makes it difficult for the operator to don without it having contact with the floor. Complex gowning can increase contamination and reduce productivity — 10 percent of gowning is repeated due to contamination during the gowning process.
Some disposable apparel is designed with innovative features that keep the garment from touching the floor during the donning and reducing the risk of the garment becoming contaminated … something that can’t be guaranteed through your launderable garments.
1. McIlvaine, R. and Betty Tessien, Disposable Cleanroom Garment Use and Markets, The McIlvaine Co.
Nina Helme is with Connect 2 Cleanrooms, based in Lancaster, U.K. www.connect2cleanrooms.com