Charity

Pharma Tech Industries, a pharmaceutical contract manufacturer and packager of powder products, recently introduced a highspeed bottling line for the production of Rx, OTC, and nutritional ingestible products at its facility in Union, Mo. The bottling line is housed in a new, specially-built ISO 8 Class 100,000 controlled environment designed for non-sterile Rx pharmaceutical-grade oral products. All equipment is of modular, quick-change design to enable minimal downtime between campaigns.

Controlled Environments spoke with Tee Noland, Chairman and CEO of Pharma Tech Industries, about this cleanroom facility addition.

A clean room design requires careful consideration of its intended use, permissible particle concentration, location, manufacturing process and of course cost. The design and specification of a clean room require close coordination between the many departments impacted by it and the design team. Certain products, such as pharmaceuticals and medical devices, must be built in a sealed and sterile environment to avoid contamination and ruin.

1. Understand your process before you engage in building a cleanroom.
2. Gather a team from all disciplines — manufacturing, quality control, compliance, purchasing, facilities — who will understand the expectations of both you and your customers. Prepare for expansion now ... don’t wait until later.
3. Prepare the scope of work required.
4. Make sure you are working with a qualified engineering team and builder.
5. Get a certifier involved as a member of your team.
6. Archive all documentation throughout the pre-design, design, and manufacturing processes. Documentation from close out is imperative for moving forward. Expect and demand great close out documents.
7. Negotiate fair progress payments.
8. Check the financials of the contractor and their subs, to make sure they can carry the project costs.

Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. These are the things that need to be considered when building an effective contamination control room.

The professional cleaning industry is changing more and evolving faster today than at any other time in its history. While this is happening, the majority of cleaning contractors are so busy with their day-to-day business operations, they may not see even more changes coming right around the corner. 

Ron Segura, president of Segura Associates, one of the industry's leading cleaning consultants working with both cleaning contractors and facility managers, says to deal with these changes, we must take steps now to "future-proof" our businesses. 

Today, when most of us purchase a new electronic device, just about whatever it is, the first thing we do is take it out of the box, plug it in, and start it going. No reading manuals; no watching instruction videos; if a quick start-up guide is included, maybe we’ll take a look at it.

The problem with this plug-and-play mentality is that we can pay a high price for it. We typically do not reference the manual until something goes wrong. Very often at that point, we find out the problem we are now facing could have been avoided with proper equipment maintenance practices — what started out as a minor equipment issue has now become a major repair cost.

When it comes to cleaning equipment, the high price that managers of controlled environments may pay can be very high indeed. This is why they must stress that their cleaning professionals, whether in-house or contracted, properly maintain their cleaning tools. For instance, if airborne dust is released from a poorly maintained vacuum cleaner, it can damage work areas and experiments. Poorly maintained floor machines can do the same as well as possibly damage the floor’s finish or the floor itself. The point is this: plug-and-play is great, and a time saver; but disregard plug-and-maintain when it comes to cleaning equipment at your own peril.

To help cleaning professionals and administrators avoid these pitfalls, below are some common equipment maintenance issues often included in the owner’s manual that get lost in our plug-and-play world.