Monday, 11 October 2021

Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity



 

The presentation of pharmaceutical preparations in the form of prefilled syringes continues to grow. The addition of drugs in prefilled insertable and disposable cartridges is driven by manufacturing economics (including the avoidance of overfill, common with dispensing into vials, which saves on product yield); clinical preference, including better accuracy of dose delivery and avoiding the cross-contamination that can occur with a separate syringe and vial; and an expansion of medications that can be self-administered by the patient in the home. The syringe plays a dual role in the prefilled syringe product — as a container closure system and as a delivery device.

 

 

Prefilled syringes vary in terms of their method of manufacture, method of filling syringes with a drug product, and the types of syringes available. Several variations are required due to product incompatibility in particular drug combinations and material types. Products in prefilled syringes must be chemically, physically, and biologically stable and, based on the route of administration, the combination product must be sterile and apyrogenic. Product manufacturing requirements are set out in the ISO 11040 standard, such as Part 8, which presents the “Requirements and test methods for finished prefilled syringes.” One important aspect of assessing prefilled syringes relates to the integrity of the filled syringe. The process of assessing integrity is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

 

Reference:

 

Sandle, T. (2021) Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity, Pharmaceutical Online, 18 August 2021; https://www.pharmaceuticalonline.com/doc/prefilled-syringes-best-practices-for-using-x-ray-analysis-to-assess-container-closure-integrity-0001

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 8 October 2021

Tips For Hazardous Chemical Handling In A Lab



 

Working with hazardous chemicals is a necessary danger for lab professionals in the pharmaceutical and medical fields. From flammable liquids such as alcohols to fume and direct contact risks, some of the most powerful and effective results of pharmaceutical research come from work with volatile, dangerous materials.

These materials can include acids, nitrates, sulfates and far more. Proper safety practices and handling are critical for a healthy workplace when dealing with these materials. Below, we will review some of the most important safety tips to protect your workers, facility and business.

Safety Tips for Hazardous Chemical Handling

Proper safety practices and training are your most effective defense against incidents involving hazardous chemicals and your workers. Without a comprehensive safety plan, you risk the health of your employees, the reputation of your business, and the results of your research and development investments.

The following tips can help protect against safety incidents:

·         Keep real-time, 1:1 records: Confirm that employees and managers are aware of the chemicals that are entering the facility and the lab setting, in real time. Lab workers should understand and acknowledge the specific materials with which they are working, so they know the correct handling procedures, potential interactions and risks. Records should be kept in real time for maximum safety and accuracy — not after the fact.

 

·         Develop comprehensive standard operating procedures: A well-planned standard operating procedure (SOP) is among the most effective ways to prevent safety incidents. The SOP should include the details of day-to-day functions (such as lab startup and shutdown), standard personal safety standards such as PPE, documentation requirements, inventory standards, incident reporting and more. The SOP should be reviewed and readily available to all employees, but most critically those who are in direct contact with chemicals.

·         Instill a safety culture through training and example: Safety training is unlikely to be effective if it is treated as a one-day “necessary” requirement. Safety starts culturally, at the top, and is most effective when it becomes an organizational standard. In addition to leading by example, consider proactive positive reinforcement such as safety record benchmark tracking, educational certifications and other methods.

 

·         See that the proper infrastructure is present: From fume hoods to air circulators, lab infrastructure is on the frontline of protecting workers. Not only must this equipment be present, it must be kept in good working order, tested regularly, and reported if any aberration or malfunction is detected.

·         Train all employees on immediate incident response: Chemical spills and other incidents are bound to happen, even with comprehensive training and SOPs in place. The first few minutes after an incident are often critical not only to the safety of the employees involved, but also to the long-term effects of the accident. Strive to ensure that all employees are equipped to quickly and safely respond to incidents.

 

·         Practice accountability: Hand in hand with the culture of safety, personal accountability can be a hugely effective tool in helping employees adhere to these standards. Instill practices such as the “buddy system” and safety accountability in performance reviews so that workers remain aware of the importance of a safe facility.

·         Go beyond the baseline: Safety training, SOP development and facility infrastructure are an excellent start for a safe facility. Yet to be truly effective, these practices must be instilled and repeated: regular retraining, equipment checks and testing, SOP review and fine-tuning, and more. Safe chemical handling is only possible when it becomes second nature to workers, and these are some of the best ways to achieve that goal.

It is difficult, if not impossible, to overstate the importance of lab safety for chemicals in the pharmaceutical and medical fields — most importantly, in your responsibility to your employees, but also for the ongoing effectiveness and viability of your facility and business. With these tips at the ready, you are now prepared to instill the tenets of a safe lab facility.

 

Author bio: Steve Gonzales is CEO of Technical Safety Services, which provides testing, certification and calibration of equipment and controlled environment crucial to the success of the biopharma, medical device, academic research and food production industries.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday, 7 October 2021

Applications of aseptic connectors



 

The application of single-use, sterile and disposable technology is encouraged by regulators, as the draft to EU GMP Annex 1 indicates. Such technology can increase the level of sterility assurance and reduce the environmental impact of processing at the pharmaceutical facility. Aseptic connectors (and disconnectors) are an important example of such technology, permitting the continuation of the fluid path by using devices designed to ensure no microbial contamination ingress. With aseptic processing, any connection undertaken post- sterilizing grade filter is of particular importance.

 

It is necessary for pharmaceutical manufacturers implementing aseptic connectors (or changing from one supplier to another) to evaluate the robustness of the connector and its ability to connect, plus aspects of the weld, and the sterilization method, as part of the Contamination Control Strategy. This article considers the microbial risk factors and the areas to examine, which can be used as the basis of questions to be directed at an aseptic connector supplier as part of the quality audit process. There are other considerations for aseptic connectors, which need to be considered as part of Quality by Design, such as product interactions through leachables and extractable testing, disinfectant compatibility, particulate release, and the design ergonomics. While important, these are not addressed in this article; the focus here is with microbial control.

 

On this topic, Tim Sandle has written an article:

 

Sandle, T. (2021) Microbial Considerations for the Selection of Aseptic Connectors, American Pharmaceutical Review, 24 (3): 16-20 At: https://www.americanpharmaceuticalreview.com/Featured-Articles/575211-Microbial-Considerations-for-the-Selection-of-Aseptic-Connectors/

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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