One of the most important aspects of an organization’s success, is teamwork. We see examples of this in many areas of life. Whether it’s business, politics, sports or even our personal lives, teamwork plays an important role.
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The ISPE Boston Area Chapter will hold its 29th Annual Product Show on September 16, 2020 at Gillette Stadium in Foxborough, MA. ISPE Boston is looking for individuals to present educational seminars. Please use the button below to present your ideas prior to February 24, 2020.
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The holidays are finally behind us, along with large, complex dinners and family gatherings. Between Thanksgiving, Christmas, and other holidays, many of us played host and were expected to present a meticulously prepared, extravagant spread for our guests to enjoy.
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There is a current, popular trend called the “Konmari” Method created by Marie Kondo, which basically teaches you how to organize your possessions and life around you. This method, when put into practice, is designed to organize a person while keeping what is important and valuable and eliminating that of what is not. Overall, the message behind the method is about one key word – “Organization”.
ICQ Consultants, Michael Gatta and Peter Broomes will be attending tonight’s PDA New England Dinner Meeting & Berkshire Facility Tour. Please make sure to stop and say hello to them if you are there! The link below will provide the events agenda and description.
Biological indicators (BIs), as defined by ANSI/AAMI and ISO, are test systems containing viable microorganisms providing a defined resistance to a specific sterilization process. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, providing a level of confidence in the process. Endospores, or bacterial spores, are the microorganisms primarily used in BIs. These microorganisms are considered some of the toughest ones to kill. Additionally, bacterial spores are chosen for a specific sterilization process based on their known resistance to that process. For example, Geobacillus stearothermophilus spores demonstrate a high resistance towards steam and vaporized hydrogen peroxide and are therefore used in BIs that monitor these sterilization processes.
Biological indicators, depending on the specific type, can be used for various sterilization processes using steam, hydrogen peroxide gas, ethylene oxide and more. Several factors such as operator experience, load preparation and sterilizer condition can impact the sterilization cycle. BIs provide a direct measure of the lethality of the process and so the use of BIs to routinely monitor sterilizers provides assurance in the efficacy of the sterilization process. BIs are typically used within process challenge devices (PCD) that are designed to represent the most challenging products routinely processed. A passing result for the BI within this defined challenge demonstrates that the sterilizer is effective in killing many highly resistant bacterial spores, providing users with a level of assurance in their sterilization process.
Fastening BIs – Pitfalls and Tips
There are many ways to fasten BIs to your thermocouples, depending upon your specific activity. For example, utilization of BIs can vary from creating new loads for an autoclave or for a steam-in-place for a Bioreactor and transfer lines. It also depends on what type of materials are available (tie wraps, zip ties, autoclave tape, screens, etc.). The main idea here is to secure the BI while still allowing steam penetration. In an autoclave you have virtually no chance to overly damage/lose BIs because they are usually in tubing, autoclave bags, assemblies, etc. versus a steaming process in a transfer line. In which case, the steam and condensate flow in the lines can damage your wet BIs and also potentially damage your BI fastener causing you to lose them in the lines. For example, fastening a BI with the improper tie wraps could melt the tie wraps to the BIs and piping.
Practical Methodology
When wrapping the BIs for an autoclave, fold the BI around the thermocouple (towards the tip of the TC) by folding the BI so it resembles a mini-burrito. I have used autoclave tape on the BI edges to hold it to the TC and have also used tie-wraps. Either way, ensure the tape or tie wraps aren’t too tight (twist tie wrap a few times) to rip the envelope of the BI. Then place the BI with the TC into your load items.
When fastening the BIs for tanks/process lines, place the TC in the BI, fold it like a burrito, and then fold it in half. Take the tie wrap (approximately a foot long) and twist it around the BI starting at the top. With the remaining length of the tie wrap, twist it together so it secures the BI from moving. Since this one is a bit harder to visualize, refer below for a picture. It reminds me of a bottle rocket. Then you can either attach it to the TC or place it in the piping beside the TC ensuring an inch or two is secured by the clamp. This prevents the movement of the BI.
In Closing…..
Like many processes, there are multiple ways to get the job done. If this blog saves even one BI and an Engineering/Validation person’s resultant frustration, then it was all worth it!
Lack of experience with project scheduling by project team members is one of the biggest frustrations that a project manager/project scheduler faces. Projects in a matrix organization are often staffed with team members who are not familiar with project schedules. The team members provide input on tasks that they will need to perform to complete the project, but many times don’t include the pre-requisites for completing the tasks. Hopefully, after reading this blog, you might be able to contribute to a more accurate schedule.
Let’s Get to it!
We will work on a project where Equipment X is purchased and qualified for use. First thing, we need to do is identify all tasks involved in making toast and an estimate of how long they might take.
Now we put tasks in the order in which they need to be completed. We start out by purchasing the equipment. Many times in the biotech industry, the equipment has a long lead time because the equipment is not off the shelf and the manufacturer has to build it. Then a field acceptance test may need to be performed at the manufacture’s site to ensure that the equipment is working as expected before it is shipped to the site. Finally, it gets shipped to the site and is installed.
All those tasks were completed serially (one after another). In a project schedule, that is a finish to start (FS) relationship. When one task finishes, the next one can start. The task that finishes is called the predecessor and the one that is starting is the successor. The predecessor to “Installation” is “Delivery to site”.
Once the equipment is installed, the qualification activities can begin. First, the equipment start up and site acceptance testing. While this task is being completed, the commission protocol could be drafted in parallel. If the Subject Matter Expert forget to tell the project scheduler that these tasks can be completed in parallel, the project scheduler may assume that they need to be completed serially. The incorrect assumption would have resulted in a schedule that is inaccurately showing as taking two weeks longer, because the commissioning protocol would not have been drafted until the Startup and Site Acceptance Testing were completed. The schedule can easily be corrected for small issues such as this as long as the information is communicated to the scheduler.
In this example, the PQ execution start requires the IOQ Report to be completed and the PQ protocol to be completed. Let’s assume that Equipment X is a single use bioreactor that requires some single use bags for the PQ execution. If the project scheduler is not told that bags are needed and are a long lead time, the schedule will not have a task in there to remind them to purchase bags for the PQ. A lot of the times that there are delays with projects, it is due to small issues such as this, where the schedule is not capturing all the tasks and dependencies (ties between the different tasks).
In Closing….
To make your life and the project scheduler’s life easier and to be able to have a more accurate schedule, do the following:
Identify all the tasks that need to be completed for your part of the project
Estimate how long you think it might take to complete those tasks
Communicate this information to project schedule along with information such as Task A, B, and C need to be completed for D can start and A, B, and C can be completed in parallel.
When you get a copy of the schedule and you see something that doesn’t make sense, talk to the scheduler.
It may take a few iterations to come up with a schedule that has enough detail to ensure that project will not be derailed, so again, communication is necessary.
If you want don’t understand something about how the schedule has been setup, ask the project scheduler. Most of them will be more than happy to explain.
Related Terminology and Great Links
Activity: A task or process to be accomplished in a set period of time as part of working toward a larger project goal. An Activity can be assigned to a resource(s) and have an associated cost. Activities are ordered with logic links.
Activity Relationship: An ordered link between 2 activities representing the order of execution.
The 4 relationship types are:
FS – Finish to Start
SS – Start to Start
FF – Finish to Finish
SF – Start to Finish
Critical Path: A project’s critical path is the sequence of network activities which add up to the longest overall duration. This determines the shortest time possible to complete the project.
Float: Float is the amount of time that an activity in a project network can be delayed without causing a delay to: subsequent tasks (free float) or the project completion date (total float).
Gantt Chart: A time-based activity chart in which a series of horizontal lines shows the amount of work done or production completed in certain periods of time in relation to the amount planned for those periods. (example is shown above)
Predecessor(s): A predecessor activity is an activity that determines the start date or finish date of a following activity based on a logical relationship.
The Work Breakdown Structure (WBS): WBS is a hierarchical and incremental decomposition of the project into phases, deliverables and work packages. It is a tree structure, which shows a subdivision of effort required to achieve an objective; for example a program, project, and contract.
https://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.png00Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2019-10-04 18:40:182020-03-04 00:31:05Project Schedules: How to Help Yourself and the Project Scheduler
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ICQ Consultants, Michael Gatta and Peter Broomes will be attending tonight’s PDA New England Dinner Meeting & Berkshire Facility Tour. Please make sure to stop and say hello to them if you are there! The link below will provide the events agenda and description.
indicators (BIs), as defined by ANSI/AAMI and ISO, are test systems containing viable microorganisms providing a defined resistance to a specific sterilization process. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, providing a level of confidence in the process. Endospores, or bacterial spores, are the microorganisms primarily used in BIs. These microorganisms are considered some of the toughest ones to kill. Additionally, bacterial spores are chosen for a specific sterilization process based on their known resistance to that process. For example, Geobacillus stearothermophilus spores demonstrate a high resistance towards steam and vaporized hydrogen peroxide and are therefore used in BIs that monitor these sterilization processes.
In this example, the PQ execution start requires the IOQ Report to be completed and the PQ protocol to be completed. Let’s assume that Equipment X is a single use bioreactor that requires some single use bags for the PQ execution. If the project scheduler is not told that bags are needed and are a long lead time, the schedule will not have a task in there to remind them to purchase bags for the PQ. A lot of the times that there are delays with projects, it is due to small issues such as this, where the schedule is not capturing all the tasks and dependencies (ties between the different tasks).
