Pharmaceutical manufacturers face many challenges in maintaining an optimum cleanroom environment, but two pain points continue to pose threats to employees and risks to manufacturing processes. First, there is the danger of employees that handle hazardous drugs such as cytotoxics that expose workers to harmful workplace environments. As the pharmaceuticals process chain moves from raw chemicals storage to intermediate compounding and into their final and stable medicinal product, the second issue arises. That is the contamination of cleanroom environments which can ultimately affect the purity and the quality of the manufactured drug.
Clean room contamination is limited when the concentration of airborne particles is tightly controlled. This is accomplished by good clean room design, the way the room is cleaned and disinfected, along with the method and type of operator gowning of PPE (personal protective equipment). The influx of contaminated air within pharmaceutical processing environments is mostly contributed to the microorganisms and particles that are shed from the people working within the area.
According to The Institute of Validation Technology:
"While there are multiple sources for particle generation, personnel are the main contributors of particles in cleanrooms as well as the primary source of microorganisms. Hence, while a risk can arise from the influx of contaminated air into a cleanroom this is less likely to occur within a correctly functioning cleanroom with effective air filtration; the greater risk is with what happens to particles shed from people working within the cleanroom when such particles enter the air stream."
Controlling Worker Exposure to Process Toxins
Occupational exposure to hazardous drugs can occur from aersolized toxic dust, or during the transfer of dissolved substances, and when dry solids are dropped or otherwise allowed to exit their safety containers, such as a defective vial. The number of inadvertent mishaps that can occur when working with cytostatics and many other toxic raw chemicals during pharmaceuticals processing is limitless. For this reason, health and safety regulations demand suitable precautions be taken to protect workers from potential industry hazards, including periodic risk assessments according to Federal OSHA’s 29 CFR 1910.132 - to make sure current protective measures are still performing suitable.
Establishing workplace controls starts with first eliminating the hazard or making appropriate manufacturing substitutes when necessary. Cleanrooms must have both environmental controls and administrative controls, which includes the mandated use of PPE to minimize risk of product and personnel contamination from processing and throughout the handling chain until final packaging.
Increasing Pharmaceutical Purity With PPE
Aseptic manufacturing demands processes that are free from contamination caused by harmful viruses, bacteria, or other microorganisms. The pharmaceutical industry faces potential losses of millions of dollars each year due to a contaminated pharmaceutical product. Cross-contamination between chemicals, foreign material transferred from workers to process equipment, and biological contaminants from an employee with unclean hands or the beginnings of a viral infection are just a few ways pharmaceuticals are exposed to non-standard impurities.
Impurities in pharmaceutical products can also negatively affect patient safety and the companies bottom line when consumer confidence is lost. Impurity levels are so critical during pharmaceutical manufacturing that detailed scientific analysis goes into determining the formation, fate, and purge of impurities during the manufacturing process. An employee contaminated chemical during the initial material handling phases can have a downstream impact on product purity that will trigger a quality control decision during end-product testing.
For both worker and process protection, the optimum PPE should provide a barrier from hazardous chemicals and dusts and be constructed of a sterilized, breathable material that does not shed fibers within cleanroom environments.
PPE Factors for the Pharmaceuticals Industry
Comfort and Control by Design
PPE considerations for the pharmaceutical industry often starts with a discussion of the fabric's ability to contain contaminants or prevent worker exposure to the risks they present. But, the fit and comfort of chemical coveralls are also crucial. PPE comfort is a control measure that allows workers to stay focused on accomplishing detailed tasks that demand a range of movement, allowing them to perform these tasks with a higher level of confidence - both of which contribute to better productivity and quality. Some key design features of PPE for sterile disposable coveralls, frocks and boot covers include:
- Tunnelized elastic at ankles and wrists for comfort and secure closure.
- Low linting material and no raw edges that can promote airborne fibers.
- Durable material that resists tears and has strong seams for worker confidence.
- lndividually packaged and pre-sterilized to a 10-6 sterility assurance level (SAL).
The triple protection needed between worker, process, and product requires a liquid and particulate barrier material that performs well as the last line of defense against cross-contamination.
Low-Particle Shed, Barrier-Proof Fabrics
When employees don sterile gowns to prevent particle intrusion from hazardous drugs, the process operations must also be ensured against particles that can be shed from the worker's clothing or skin. Protective clothing for pharmaceutical manufacturing should be of a low linting, synthetic material that features an endless (or continuous) fiber weave or a non-permeable barrier film.
- High-density polyethylene such as Tyvek (DuPont) is a flashspun material used primarily in the construction industry to protect workers from small size hazardous particlesâ€‹ such mold, asbestos, fiberglass insulation, and lead. It is also used for sterile packaging applications in the manufacture of medical devices to prevent cross-contamination.
- SMS or Spunbound Meltblown Spunbond - is a triple laminated fabric that is non-woven. The fabric consist of a top layer of spunbond polypropylene, a middle layer of meltblown polypropylene and a bottom layer of spunbond polypropylene. This material has reliable strength and durability, along with excellent wicking and barrier properties against fluids and particles.
- Microporous film (MPF) - is a polyethylene (PE) sheet that has microscopically small pores. This film is layered on top of a spunbond base to create a barrier layer of protection of only 0.02 mm which gives it a low resistance to abrasion. Microporous film (MPF) is an economical chemical barrier disposable product that offers dependable protection against chemical dust, sprays and light liquid splashes.
Other tips for picking the right PPE apparel include having a smooth surface to limit particles that may adhere to PPE wear and materials that have been treated to achieve anti-static properties. They should be liquid tight at the front and at the arms with a tightly sealed cuff. Pharmaceutical PPE should be breathable, comfortable, and fully protective to minimize risks to both personnel and product.
International Enviroguard manufactures disposable protective clothing for protection from chemical liquids, dust, and particles to keep pharmaceuticals manufacturing process sterile and workers protected from contact with hazardous drugs.