Pharmaceutical Laboratory Design

Pharmaceutical Laboratory Design

Posted on the June 9th, 2020

Guidelines to a pharmaceutical lab design and construction

When designing labs for medical and pharmaceutical companies, the projects we are asked to tackle are varied. Pharma companies across the UK produce millions of products every day, each with different routes of administration, dosage form and release patterns, however, one thing remains common among all pharmaceutical companies – an effective laboratory design space will increase profitability dramatically.

Take a look at our recently completed laboratory installation with Nanopharm.

Tablet Testing

The pharmaceutical industry spends $160 billion per year on research and development. The potential value of tablets and other drugs means this industry is worth millions of pounds. With clinical trials stages to get through, labs are being pushed all the time with the tight time pressure of getting drugs to market.

In a busy pharmaceutical laboratory, routine checks must be completed. Dissolution, Disintegration, Friability, Uniformity of dosage units, Water content and Microbial limits must all be examined and proved successful.

But with all these checks come the equipment. Disintegration Testers, Dissolution Testers, Friability Testers, Next Generation Impactors, Vacuum Pumps, Differential Pressure Meters, PH Meters, Dissolved Oxygen Meters, where are they all going to be located?

Start by drawing a flow diagram or Critical Path Analysis (CPA) to identify possible hold up areas and time delays that may be occurring in your testing/production line. The positioning of equipment is key and can save days over a long period of time. Where do samples enter the laboratory? Having a set-down area with a transfer hatch from production can be a time-saving efficiency that also contributes to better procedure and contamination control.

Good Manufacturing Practice (GMP)

Do you comply with GMP regulations? Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Designed to minimize the risks involved in any medical, pharmaceutical production that cannot be eliminated through testing the final product, the key elements to consider are:

• Buildings and Facilities
• Equipment
• Equipment Maintenance, Cleaning and Calibration
• CGMP Validation
• Cleaning Validation
• Production and In-process Controls
• Materials Management
• Packaging and Labeling
• Laboratory Controls
• Personnel
• Complaints and Recalls
• Change Control
• Computer Systems
• Specific Drug Product Regulations

Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and even jail time.

Managing API’s

Managing API’s is also very important in medical laboratory design. Active Pharmaceutical Ingredients are the part of a pharmaceutical drug that is biologically active. The welfare of operatives must be taken into account and adequate ventilation and extraction provided with fume cupboards.

Also, the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations must be looked into and suitable plumbing and drainage monitoring systems put in place.

Clinical Trials

Smooth Clinical Trials can be the making or breaking of a drug. Comparing the effects of one treatment with another, clinical trials often involve patients, healthy people, or both and are essential to get right. The UK Clinical Trials Gateway (UKCTG) is a good source to find out about trials happening currently.

Ensure your medical lab design has a section dedicated to the rapid response to this phase of development. Keeping things moving will ensure your drug reaches the market as early as possible.

The next step – contact us to discuss your pharmaceutical laboratory design requirements. Our dedicated team are on available to help.
Telephone our office on 01275 464220
Or email us at [email protected]

Alternatively, have a look at our recent article on specialist lab design with Kastnerlab.

The team, Kastnerlab.

 

Nanopharm and Kastnerlab