Life Sciences | Controlled Environments Magazine

Aseptic Processing

Validation Readiness, Part 2
Planning and pre-testing are keys to successful validation. Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.
Peristaltic Aseptic Filling Machines With a Single Use Production Philosophy
New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches.
When Worlds Don't Collide--But Ought To
Pharmaceutical and medical device manufacturers tend to operate in separate worlds. The products are different; the cultures and customary manufacturing practices are different; the regulations are often different. For the successful manufacture of combination devices, there must be a harmonious fusion;1 so the two worlds collide, albeit with some reluctance.

Mgmt & Safety

Ask the Facilities Guy
Question: Our company has just published a disaster recovery plan. What should I do now to ensure the plan doesn’t become a ‘bookcase trophy? ’ Answer: “The best laid schemes of mice and men go often askew.” Robert Burns, 1785
Ask the Facilities Guy: Key Elements in Facility Maintenance Plans
Question: What are the key elements I should include in my facility maintenance plan to ensure a “clean power” supply? Answer: When it comes to power supplies for clean manufacturing facilities, and their support areas, there’s truth in the adage that “an ounce of prevention is worth a pound of cure.” Failure to develop and adequately resource installation guidelines and a Planned Maintenance Schedule aimed at your power systems can result in:
On the Journey to Net-Zero: An Approach to Increasing Energy Efficiency in Laboratories
It is a well-known fact that laboratories consume extraordinary amounts of energy—as much as three times the energy of regular office space.

Particle & Microbial Testing

Changes Affecting EU GMP and The FDA's CGMP Non-Viable Particle Cleanliness in Cleanrooms
What the revisions to ISO 14644 may mean to your cleanroom EU GMP and the FDA’s cGMP set the target cleanliness levels for non-viable particles in pharmaceutical cleanrooms. Both documents refer the reader to ISO 14644 for the methods to determine these cleanliness levels.
Water Under The Bridge -- In Process Monitoring, Part 2
Manufacturing problems can lead to large costs of rework or can result in product becoming scrap. Immediate detection of problems is a key to increasing productivity and decreasing costs. When problems are associated with surface contamination, an array of tests can be performed quickly in conjunction with the manufacturing process, avoiding the need to send samples to a lab and await results.
Water Under The Bridge -- In Process Monitoring Part 1
AVOID WATER UNDER THE BRIDGE

USP 797

The Microbial Bioburden of USP 797 Compliance
Simplifying environmental quality and control practices for pharmaceutical compounding Issued by the nonprofit United States Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), USP Regulation 797 is the first enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest revision became official on June 1, 2008.
Containment of Hazardous Drugs: The New Paradigm
Compared to pharmaceutical manufacturing, hazardous drugs have a narrow definition in the world of pharmacy. This article will compare and contrast the differences in the approach and knowledge base that exists in both worlds, in terms of defining and coping with the hazards these drugs represent.
Cleaning Protocols for USP 797 Compliance
Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine.

Clean Packaging

Extrapolate To Production: Quality and Economics
Let us assume there is a promising prototype for a critical product, a prototype for which we have reached the “ah-ha” moment. Perhaps half a dozen have been produced and pilot tested. If the product is a medical device, biocompatibility testing or even clinical trials may have started.
When Worlds Don't Collide--But Ought To
Pharmaceutical and medical device manufacturers tend to operate in separate worlds. The products are different; the cultures and customary manufacturing practices are different; the regulations are often different. For the successful manufacture of combination devices, there must be a harmonious fusion;1 so the two worlds collide, albeit with some reluctance.
Key Considerations For Cleanroom Conveyors
The case for modular conveyors

Contamination Control

How It Works: High Performance Solution for Cleaning Thin Film
PROBLEM Cleaning thin films and addressing the impact of debris on yields, production, and quality. Highly engineered thin film is increasingly used in flat panel displays (FPD), touch panels, automotive applications, and thin film solar panels. In all these sectors there is a zero tolerance policy to defects, and the presence of foreign particles in the production process leads to high reject rates.
ASTM Medical Device Committees: Standards Evolution
During the November, 2011 ASTM meetings in Tampa, FL, we observed a number of trends, particularly in the standards and guidance documents that impact medical device manufacture and maintenance. The ongoing presence and constructive comments by individuals within the FDA has continued. Their input will be invaluable in helping industry to develop documents that assure excellent surface quality and contamination control and that are protective of the public. As illustrations, we are highlighting a few newer standardization efforts.
Cosmetics and Cleanrooms
Barbara Kanegsberg with special guest columnist Dr. Kevina O’Donoghue Reviewed by Ed Kanegsberg “I have to let off steam, Barbara. Let’s talk” said Kevina.

Regulations/Standards

Pharma Facility Quality Audits: A Primer for Design Teams
Here is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time in Quality, working on a facility or equipment project in the pharmaceutical industry, you have certainly had that put to you at some point. And why not?
Point of View Enhancing the Facility Monitoring Program
Regarding the article in the June issue (The Importance of On-Going Facility Monitoring) which brought attention to what the title of the article addresses there is another, often forgotten aspect of the monitoring program, which is the witness plate sampling and counting method as described in IEST-STD-CC1246D. This standard was formerly a military standard (MIL STD 1246). Other industries wanted the same testing conducted to verify the cleanliness of their products and controlled environments. Therefore, it became an international standard for all industries.
Ask the Facilities Guy: Key Elements in Facility Maintenance Plans
Question: What are the key elements I should include in my facility maintenance plan to ensure a “clean power” supply? Answer: When it comes to power supplies for clean manufacturing facilities, and their support areas, there’s truth in the adage that “an ounce of prevention is worth a pound of cure.” Failure to develop and adequately resource installation guidelines and a Planned Maintenance Schedule aimed at your power systems can result in: