Pharmaceutical manufacturing requires many processes and quality checks throughout the production lifecycle to verify the sterility and integrity of the product.
Environmental monitoring plays a critical role in the processing of products. Multiple resources are made available to protect the product from contamination.
Cleanrooms are used to process the product under sterile conditions and areas where the product is potentially exposed to contamination are monitored vigorously to verify the product is manufactured in a low risk environment following a validated routine monitoring plan.
Facility Monitoring System using particle counters, air samplers and settle plates are used to capture and count viable and non viable particles. Cleanroom standards are verified and maintained to make sure the process environment is free of contamination.
Product batch releases are dependent on the results from this routine monitoring.
Therefore a lot of time and effort is spent within the Product Lifecycle to protect the product before it makes it’s way to the patient which is all justifiable considering patients with low immune systems have undergone surgery and rely on safe products for their recovery.
But what about the people who work in these manufacturing environments ? How are they protected …. from the Product ?
Many pharmaceutical product’s pose a dangerous threat to the health of the people working in pharmaceutical cleanrooms but does the Pharmaceutical Industry do enough to limit the exposure of these harmful products to the personnel manufacturing them ?
Firstly cleanroom personnel wear special non shed particle free “cleanroom clothing” they gown up before entering the cleanroom wear full body covering clean room garments such as gortex body suit, hood, booties,latex gloves, face mask and safety glasses but the emphasis of this type of protective clothing is to protect the product from the people working in the processing environment.
The biggest threat to product sterility is contamination from the personnel manufacturing them. So are the workers completely covered and safe from exposure to the Product they are manufacturing ?.
Certain dangerous products such as cytotoxic * injectables, tablets, nano developed pharmaceuticals etc require extra steps in protecting the operators from exposure such as RABS, LAF & BSC technologies etc but all too often at some point the operator is in direct contact with the product either during manufacturing process at the fill head or later on when running routine quality checks on the product.
With the development of nano technology recently it is well known that the harmful effects of nano particles are still under research but the results so far have raised international concern. In traditional pharmaceutical manufacturing glass vials regularly break during processing and product is splashed and propelled into the environment, tablet processing generates plumes of dust which consists entirely of product.
So the processing environment is a dangerous place for clean room personnel who work there on day to day basis. Many pharmaceutical companies routinely do health checks and blood tests on employees working in these environments so as to pick up any anomalies and offer extra pay to employees to work in these hazardous places.
Wearing clean room clothing and Respiratory Protective Equipment (RPE) is not enough there must be some monitoring or checks in place to test the integrity of the RPE after all it’s the operators last defense against harmful exposure to dangerous products.
Legislation provides instructions for employers to protect their employees from the work environment. In Australia the recently updated ASNZ- 1715 standard for Respiratory Protective Equipment (Face Masks) requires mandatory “Fit Testing” of all employees wearing RPE. Now employers in all Industries are required to Fit Test their employees. So what is a Fit Test ?
Fit Testing ensures the wearer of RPE such as face masks chooses the right size mask, and wears the mask correctly maintaining a seal around the users face. In the Pharmaceutical Industry employees wearing face masks must be tested at least annually.
A proper Fit Test verifies that the mask is correctly sealed around the wearer face. The test is a Quantitive type of test and is based on a ratio of ambient air particles versus particle count inside the mask.
The seal is tested and the higher the ratio the better the seal. It’s the most accurate type of test available. In reality all face masks leak for various reasons some masks are cheaply manufactured and some models are not suited for the wearers face as we all have uniquely different size faces there is no one mask that fits all available.
The wearer’s face can change over time with weigh gain or weight loss or if facial hair is present or not.