Notes on compliance: Don’t just get compliant, stay compliant – Five practical ways to get USP 1116 done

Innovation doesn’t always have to be high tech – sometimes it is about finding practical solutions that drive efficiencies.

This is particularly true in pharmaceutical environmental monitoring, an unavoidable cost of business that can seldom be passed on to clients.

Continual cleanliness ​

Environmental monitoring is the control system for maintaining operations facilities according to USP 1116: Microbiological Control and Monitoring of Aseptic Processing Environments.​

The guideline covers pharmaceutical sterile products, bulk sterile drug substances, sterile intermediates, excipients, and some medical devices. It recommends facilities operate both total particulate and microbiological monitoring programs in their bid to avoid contamination and keep patients safe.

Meeting USP 1116’s microbiological standards is extremely difficult without an environment that speaks to cleanliness: ultimately facilities don’t get compliant, they stay compliant.

Keeping bioburden loads low starts with identifying and mitigating all possible risks, and relies on robust systems of continuous sampling, testing, and documentation.

It is an effective and necessary approach, but it can also reduce a pharmaceutical manufacturer’s return on investment. Luckily, there are lots of things quality control (QC) teams can do to lower costs while keeping standards high.

1)      Order in high volume​

Pharmaceutical facilities can work with thousands of plates in a single day, all of which have the potential to introduce contamination to the manufacturing process. To mitigate this risk, each batch is subject to QC testing.

Acquiring the largest lot size with the longest expiry date, then, will reduce the required number of new-batch validations, freeing up QC time and an organization’s resources.

2)      Seek out full traceability​

With thousands of plates being used in multiple departments and units, QC departments need eyes on all of them. Without full traceability, departments will find it difficult to investigate – and rectify – contamination.

Monitoring plates that incorporate individual 2D barcodes give teams the data they need to track and trace alerts.

3)      Banish cardboard boxes​

It does not matter if laboratory supplies are sterile if the box they come in is contaminated. Paperboard and paper are made from biodegradable cellulose fibers. It means microbial growth can happen at any point of the cardboard production process.

Laboratory supply partners like Thermo Fisher Scientific can provide specialized packaging, specifically designed to reduce the risk of contamination.

4)      Look for simple ways to spot risk​

Environmental monitoring is about having confidence in every step of the process, but supplies can sometimes introduce avoidable risk. Avoiding this takes time and resources.

But it doesn’t have to. Our triple-wrapped, irradiated Thermo Scientific™ Plates, for example, take cleanroom confidence to the next level by confirming the integrity of the wrapping material and seal during VHP exposure.

5)      Look for simple ways to increase productivity​

Manpower is among the biggest expenses in environmental testing, so anything organizations can do to increase productivity can make a substantial difference.

Recently, Thermo Fisher has developed color-coded settle plates, meaning technicians can quickly find the media they need and get on with the task at hand.

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Sometimes the simplest solutions are the most effective – and small changes can make a big difference to the cost of high-volume processing like environmental monitoring.

For more information on Thermo Scientific​​™​​​ environmental monitoring solutions view our SmartNote ​​ ​