![]() ![]() ![]() Then, there are the financial resources required to buy said stones. That’s not to mention the fact that getting your hands on the biggest, best stones requires relationships, and these are often centuries deep. “Why would they choose you over somebody they’ve already spoken to for generations?” Grant says. Cat Buckle Up Buttercup You Just Flipped My Witch Switch - Buckle Up Buttercup You Just Flipped My - T-Shirt TeePublic Shop Cat Buckle Up Buttercup You Just Flipped My Witch Switch buckle-up-buttercup-you-just-flipped-my t-shirts designed by BramCrye as well as other buckle-up-buttercup-you-just-flipped-my merchandise at TeePublic. For one thing, high-level collectors are far more likely to buy from established brands. Buckle Up Buttercup You Just Flipped My Witch Switch, Funny Witch Tshirt, Funny Cat Witch, Halloween Tshirt, Celestial, Witch, Witchcraft. This landmark price tag reflects Grant’s belief that, “economic power is the Cat Buckle up buttercup you just flipped my witch switch shirt so you should to go to store and get this basis for real change,” and represents a watershed moment for an industry which has historically been dominated by the white, wealthy, and well-connected. Cat Buckle up buttercup you just flipped my witch switch shirt, hoodie, tank top, sweater and long sleeve t-shirt Castro NYC-purveyor of uncanny, gem-encrusted doll necklaces-is inspired by the continent, too. Cat witch Buckle up Buttercup you just flipped my witch switch shirt I will buy this ladies working at my local VS store and other panty department stores. When you had the Witch Black Cat Buckle Up Buttercup You Just Flipped My Witch Switch Shirt also I will do this idea to write the book, did you always want. If it sells, it will set a record for the most expensive jewel by a Black designer sold at a major global auction house. Shop now Buckle Up Buttercup You Just Flipped My Witch Switch Shirt Halloween. At the top end of the scale is a million-dollar ring that has been custom-made for the occasion by Maggi Simpkins. The show, curated by Grant in partnership with Sotheby’s director of jewelry Frank Everett, will feature roughly 60 pieces, with prices starting at $1,500. Opening on September 17th, Brilliant and Black: A Jewelry Renaissance will showcase the Cat Buckle up buttercup you just flipped my witch switch shirt so you should to go to store and get this work of 21 Black designers from across the US and Europe. ![]()
0 Comments
![]() ![]() ![]() It’s a small price to pay for a piece of mind and an incredible automated service. I’ve been using Backblaze to automatically backup my computer and my wife’s computer for well over a year now, and we only pay $12/mo. It’s an incredible value and well worth the money. ![]() IDrive An excellent all-around choice Specifications Storage capacity: Up to 10TB (up to 50TB for business plans) Number of. The Backblaze service includes the ability to backup your entire hard drive, no matter what the size is, for only $6/mo. The best cloud storage services today (Image credit: IDrive) 1. If your computer is ever lost or stolen, you may be able to recover it using their Locate My Computer feature. You have the option to download a zip file for free, or you can pay them to ship you a DVD or USB Hard Drive with all of your files.īackblaze also includes a feature you wouldn’t expect from an online backup service, the ability to locate your computer. They provide an excellent web application if you ever need to view or restore your files. You can pull the throttle down to prioritize network and Internet speed or push the throttle all the way up to maximize the outgoing upload limit of your Internet connection.īackblaze comes with the ability to schedule your backups and makes it easy to exclude unwanted folders and file types. The Throttle allows you to control the speed at which files are uploaded to their backup server. One of my favorite features in Backblaze is the Throttle setting. Here are ten common mistakes you want to avoid. You can also pay 130 every two years for the service. jasonfitzpatric Reviewed By Chris Hoffman May 30, 2023, 7:00 am EDT 7 min read Justin Duino / How-To Geek Backing up your files on your computer, phone, and other devices is a crucial part of modern life, but it’s all too easy to do it wrongeven when you think you’re doing everything right. Backblaze charges 7 per month or 70 per year and offers unlimited cloud backup storage for one computer. The menu icon also provides a shortcut to its preferences if I need more details or need to change a setting. For those with just one computer to worry about, Backblaze is cost-effective compared with other online backup services. It would display unwanted messages and there was no way for me to turn them off in the preferences.īackblaze runs silently on my computer, and I can easily check the status by clicking on its menu icon. When I originally tested and used Mozy, it suffered from what I call the Windows effect. Unlike the other online backup services I’ve tried, Backblaze was not only easy to set up but also stayed out of my way. Verdict: Good Backblaze is the simplest, quickest way to backup a single device at a rock-bottom price. By Whitson Gordon Updated: 12:20 pm Posted: 2:15 pm Be sure to visit IGN Tech for. They include ease-of-use, functionality, and affordability. IGN Review Backblaze Cloud Backup Review 5 a month for unlimited storage. There are three key elements to a cloud backup service that I require. I’ve tested several mobile backup services, and Backblaze is easily my favorite. ![]() ![]() ![]() Simple and Sweet (via Frog Prince Paperie) Spice up your kid’s lunch with these cheerful sayings. Inspired by Winnie the Pooh Quote (via I Heart Naptime) A wonderful old-fashioned tag with a heartening quote from the classic children’s character. Cut each of the notes with a pair of scissors. Download and print the lunchbox notes on to regular copy paper. These are perfect for kids attending traditional school and even those learning from home. Simple Yellow Pencil Notes (via Blissfully Domestic) The perfect size for printing on sticker paper and putting in unexpected places. Once you have your download, you can start printing and adding some encouraging words to your kids’ lunch. Lunchbox Buddies (via Love From Ginger) Tiny envelopes contain a sweet animal buddy for lunchtime companionship.Ĭute and Bright Colorful Notes (via Maddalee)A bright, comforting message for little ones who are nervous about school. Retro Vintage Notes (via Persnickety Prints) Old school notes with retro prints and binder paper rule. Modern Notes (via Kiki and Company) Inspirational sayings will brighten up any kid’s day.īack to School Jokes (via Paging Supermom) Silly school-themed jokes your kids can share with their lunchmates for a laugh. The day won’t seem so long for your little ones with a surprise note from home. ![]() Just print them out and slip them into your kid’s backpack or lunchbox for a midday pick-me-up. Battle back-to-school blues with these bright notes of encouragement and cheer. ![]() ![]() “Using … proprietary silicon photonics technology, designed a novel computer architecture that can scale drastically more efficiently, allowing users to train models that are 100 times to 1,000 times larger in tractable amounts of time, at substantially reduced costs, and with a drastically simpler programming model,” Gomez said. This allows us to feed data into processing chips across a much larger memory space, and scale AI algorithms across more processors more easily. By contrast, Luminous hardware uses light channels, which can send more data between chips, and data links don’t degrade much as a function of distance. In traditional hardware, data is sent along electrical wires, which consume far more energy and send far less data the longer they are. Stagnation in AI progress is incoming rapidly.” Even worse, even for, hardware growth is slowing so much that increasing model size much further is nearing intractable. Training big AI models is mostly relegated to, as most companies can’t even afford to rent the necessary hardware. Existing big AI models today are notoriously difficult and expensive to train, as the underlying hardware just isn’t fast enough. “Unfortunately, we’ve come to an impasse: hardware simply hasn’t kept up. Ten years ago, the biggest models were 10 million parameters and could be trained in 1 to 2 hours on a single GPU today the largest models are over 10 trillion parameters and can take up to a year to train across tens of thousands of machines,” Gomez told VentureBeat via email. ![]() “Over the past decade, the demand for AI compute has increased by a factor of nearly 10,000. As for Gao, he’s the CEO at AlphaSheets, a data analytics platform aimed at enterprise customers. Gomez, who previously founded a fashion tech startup called Swan, was formerly a research scientist at Tinder and spent time working on machine intelligence and research software at Google. Nahmias’ research at Princeton became the cornerstone of Luminous’ hardware. Luminous was founded in 2018 by Michael Gao, CEO Marcus Gomez, and Mitchell Nahmias. We just don’t have the hardware that can run those algorithms.” What’s frustrating is that we have the software to address monumental, revolutionary problems that humans can’t even begin to solve. We can interact with computers in natural language and ask them to write a piece of code or even an essay, and the output will be better than most humans could provide. “It’s an incredible time to be a part of the AI industry,” Luminous CEO and cofounder Marcus Gomez said in a statement. (Post-money, Luminous’ valuation stands at between $200 million and $300 million.) So is Luminous Computing, which today announced that it raised $105 million in a series A round with participation from investors including Microsoft cofounder Bill Gates, Gigafund, 8090 Partners, Neo, Third Kind Venture Capital, Alumni Ventures Group, Strawberry Creek Ventures, Horsley Bridge, and Modern Venture Partners, among others. ![]() ![]() Lightmatter, LightOn, Celestial AI, Intel, and Japan-based NTT are among the companies developing photonics technologies. ![]() ![]() ![]() However, you do have the option to upgrade your finials (and replace the standard) by selecting from the related items offered below. Standard Features & Additional Options Top of PageĮach Estate Swing Driveway Gate comes standard with finials and end caps, depicted in the image above. We look forward to hearing from you."ĭetailed Images - Click to Enlarge Top of Pageįurther Images - Click to Enlarge Top of Page So please give us a call, send an email, or use our live chat on our website. We can put together a complete kit that you will be able to install yourself. Gate Crafters has experts standing by to help you with any question you may have 7 days a week from 9 am to 9 pm, eastern time. We strive to please our customers and offer products that install with ease. Gate Crafters started the DIY gate business on the internet. The installation of this gate is very easy and will add value to your home or business. This kit was designed for the DIYer in mind. These hinges are built to last and feature a grease fitting which keeps the ball bearing moving freely. To round out your gate kit, I recommend you order Gate Crafters' heavy duty gate hinge kit. The frame and pickets are welded at multiple locations by skilled American welders. ![]() This gives you a sturdy location to attach your gate opener and hinges. The frame of the gate is made from 2 inch square 6061-T6 aluminum bars. The gate is made from strong 6061-T6 aluminum and then are powder coated to ensure the durability of the gate. ![]() The Estate Swing gates are built for automation and strength, as well as durability. Each gate comes with our standard finial, but you have the option to order custom ones from our website. These gate come in various lengths from 12 and 14 foot single leaf gates and 14 and 16 foot dual leaf gate. "The Estate Swing pre-manufactured are readily in stock are available to be shipped to your home or business. Words From Senior Application Engineer, Anthony Gaeto Top of Page Never before has such a well designed driveway gate been so accessible and so affordably priced. With all of these features and benefits another company would charge a much higher price, but because has a special relationship with Estate Swing, we've decided to pass the savings on to you! From our loyal GateCrafters customers we've heard the request for affordable security. Keeping the manufacturing local allows for efficient quality review and substantially quicker shipping time compared to overseas outsourcing. by skilled welders which follow the American Welding Society's Standards. One other unique factor about our Estate Swing Driveway Gate Collection is that they are made in the U.S. It’s easy to drill, easy to lift, easy to automate which keeps both the DIY installation effort and cost down significantly. As gate automation professionals, Estate Swing sought to anticipate the needs of consumers and incorporate those details when designing this dynamic driveway gate. See “gate construction” below for more details on how other gate companies fail to create much needed automation support.īy using 6061-T6 wrought aluminum ¾ inch pickets and a full 2 inch square frame members we create a tough and durable gate that is stronger lighter and is almost twice as resistant to denting or bending than steel, which in turn, is safer for people and objects as well as extends the operator life since it puts less strain on the gears. Unlike other driveway gates where automation is a secondary thought, Estate Swing recognized the need for operator placement from the start therefore customer automation preferences were considered beforehand which ultimately prevents awkward looking and structurally unsound flat bars from being added later on. The design incorporates classic artistry, sturdy wrought aluminum alloy and a smooth powder coated finish. With an elegant sweeping arc and clean lines this single 12 foot long gate is functional both in its appearance and in regard to automation. Height: 5 feet on sides, 6 feet at the apexįrom the innovative brand Estate Swing known for its dependable gate automation comes the new eye catching and affordable Estate Swing Driveway Gate Collection.Gate Length + Hinge + Estate Swing 3" Mounting posts: 12 feet, 7.25 inches long.Gate Length + Hinge: 12 feet, 1.25 inches long. ![]() ![]() ![]() “The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.” – Marcel Proustģ4. It’s lethal.” – Paulo Coelhoģ2. “Travel is never a matter of money but of courage.” – Paulo Coelhoģ3. “Twenty years from now you will be more disappointed by the things you didn’t do than by the ones you did.” ― Mark Twainģ0. “People don’t take trips, trips take people.” – John Steinbeckģ1. “If you think adventure is dangerous, try routine. “We travel for romance, we travel for architecture, and we travel to be lost.” – Ray BradburyĢ9. “Wanderlust: n. a strong desire for or impulse to wander or travel and explore the world”Ģ8. “Once the travel bug bites there is no known antidote, and I know that I shall be happily infected until the end of my life.” – Michael PalinĢ7. “This wasn’t a strange place it was a new one.” – Paulo CoelhoĢ5. “If we were meant to stay in one place, we’d have roots instead of feet” – Rachel WolchinĢ6. The great affair is to move.” – Robert Louis StevensonĢ3. “I’m in love with cities I’ve never been to and people I’ve never met.” ― Melody TruongĢ4. “We wander for distraction, but we travel for fulfilment.” - Hilaire BellocĢ2. “For my part, I travel not to go anywhere, but to go. “Blessed are the curious for they shall have adventures.” – Lovelle DrachmanĢ1. “Take only memories, leave only footprints.” – Chief SeattleĢ0. “Wherever you go becomes a part of you somehow.” – Anita Desaiġ7. “A journey is best measured in friends, rather than miles.” – Tim Cahillġ6. “Once a year, go somewhere you have never been before.” – Dalai Lamaġ5. “Two roads diverged in a wood, and I – I took the one less traveled by” - Robert Frostġ4. “I haven’t been everywhere, but it’s on my list.” – Susan Sontagġ3. “Life is meant for good friends and great adventures” – Anonymousġ2. “The world is a book, and those who do not travel read only one page.” – Saint Augustineġ1. It is the traveler only who is foreign” – Robert Louis Stevensonġ0. “A good traveler has no fixed plans, and is not intent on arriving.” – Lao Tzuĩ. Hopefully, you leave something good behind.” – Anthony BourdainĨ. ![]() It leaves marks on your memory, on your consciousness, on your heart, and on your body. The journey changes you it should change you. Sometimes it hurts, it even breaks your heart. “Surely, of all the wonders of the world, the horizon is the greatest.” – Freya Starkħ. “Travel is fatal to prejudice, bigotry, and narrow-mindedness.” – Mark TwainĦ. “Don’t tell me how educated you are, tell me how much you have travelled.” – Mohammedĥ. “I am not the same, having seen the moon shine on the other side of the world.” – Mary Anne RadmacherĤ. “Life is either a daring adventure, or nothing at all” – Helen Kellerģ. “Man cannot discover new oceans unless he has the courage to lose sight of the shore.” – Andre GideĢ.
![]() ![]() Alternatively, you can remember the PC’s IP address (which is accessible by entering cmd within the Windows search box and typing ipconfig and pressing the Enter key), although if the PC receives its address via DHCP, the address will likely change over time and make that method problematic. You’ll need that name to connect to the PC from your Mac, so write it down if you cannot remember it. One method for doing so is to open the Windows Control Panel such as by entering Control Panel within the Windows search box, clicking System And Security, then selecting System. To disable Sleep Mode, click Start, select Settings and click Power and Sleep and use the provided drop-down boxes to disable those features. You may need to provide the administrator password to complete this step.īe sure to also disable Sleep Mode on the target PC otherwise, you may not be able to reach the PC if it falls asleep or turns off. Confirm the remote connection is enabled. For a Windows 10 or 11 Professional machine, which is required to access Microsoft Remote Desktop, click Start, select the Settings icon, click System and choose Remote Desktop. Step 3: Enable remote accessĪt this point, you’ll need to enable remote access on your target PC. Opening the Microsoft Remote Desktop app should look like Figure D.įigure D Before you can remotely connect to a Windows PC, you must create a connection by clicking the blue Add PC button to add a Windows computer to the Microsoft Remote Desktop app. Just click it from the Dock or double-click its Applications folder entry ( Figure C).įigure C One option for opening the program is to double-click the Microsoft Remote Desktop entry within the Mac’s Applications folder. The next step is to open the Microsoft Remote Desktop program on the Mac. This step will keep you from having to look for the icon every time you need to use it. Just click and drag the icon from the Applications folder in Finder and release it within the Mac Dock. If you think you’ll frequently use the remote desktop connection app, now would be a good time to set it in your dock. ![]() Or, you can use the Mac’s Spotlight search feature by clicking the magnifying glass icon from the Mac’s menu bar or by using the shortcut Command + Space Bar and searching for Microsoft Remote Desktop. ![]() Next, open the application by clicking the Microsoft Remote Desktop icon within the Applications folder, or by activating Launchpad and clicking its red-and-white icon. Step 2: Open the Microsoft Remote Desktop app If you’ve previously downloaded the app using the Apple account currently logged in to the App Store, you’ll see a cloud icon with a down arrow ( Figure B) just click that icon to again download the app.įigure B Click the blue Get link or cloud download icon to download Microsoft Remote Desktop for Mac. The app is free, so no price will be listed. To begin the download, click the blue Get link. The first search result should be what you’re looking for. Once you’ve accessed the Mac App Store, use the search bar at the top left of the screen to search for Microsoft Remote Desktop. You can open the Mac App Store by clicking the blue App Store icon in your Mac’s dock, selecting the app’s icon using Launchpad or by clicking the App Store entry within the Mac’s Applications folder ( Figure A).įigure A Mac users can open the App Store by clicking its entry within the Applications folder. In order to get started with Microsoft Remote Desktop, you must download it from the Mac App Store. SEE: Software usage policy (TechRepublic Premium) Step 1: Download the Microsoft Remote Desktop app Available through the Mac App Store, the free application allows Mac users to remotely connect to a Windows desktop to access local files, applications and network resources. However, a gap still exists for some and requires a bridge to move between computing environments.įor Mac users, the stalwart tool has been the Microsoft Remote Desktop connection. Today’s technology has come a long way in closing the divide between Windows and Mac applications, especially in the enterprise. For more info, visit our Terms of Use page. This may influence how and where their products appear on our site, but vendors cannot pay to influence the content of our reviews. We may be compensated by vendors who appear on this page through methods such as affiliate links or sponsored partnerships. Here's how to set up and use the connection. If you need to access Windows applications or PCs using your Mac, a remote desktop connection is the way to go. How to access Microsoft Remote Desktop on your Mac ![]() ![]() ![]() Despite this, Ecaflip forgives Kerub and he becames the God's favourite from then on.Īs Kerub stayed at the temple for a few more years he grew bored and wish's for adventure outside of the temple. In desperation (knowing he will definitely be punished for failing) Kerub creates a fake egg but the trick is resolved by the God Ecaflip. On the way back home, however, the egg is broken by Kerub's clumsiness. Kerub faced many trials and obstacles, but he prevails at the end. (A quest that must be completed in two days.) The quest was to obtain the egg of a bird that lives on top of a dangerous mountain in a dangerous forest. Kerub grow up in the temple, and when he was older enough he decided to take part in the Quest of Two Mornings. But then a disciple of the Ecaflip temple found him and decided to take him in. ![]() ![]() In his early days Kerub was a homless orphan, he was found alone on a road away from any city. A great part of his early life is exposed in the animated series Dofus: Kerub's Bazaar, where he tells stories of his adventures to his adopted son Joris after having retired in Astrub and opened a store to sell the various treasures he has accumulated. His most remarkable quality is the exceptional luck that has been bestowed upon him by the gods Ecaflip, a luck that has often been the vector of his success and fame.Īs a child, he was raised as an orphan in Ecaflip's temple, unaware of his divine heritage. As a demigod, he has lived numerous centuries and appeared in several media. Dofus Book 1: Julith Kerub Crepin is an adventurer turned shopkeeper and a demigod son of Ecaflip. ![]() ![]() ![]() Your sprocket was designed for the Profile SS crank, which has a 7/8" (22.2mm) spindle. Thanks again everybody., I hope I don't start getting into BMX bikes now! I just discovered that Profile Racing is like two/three miles away, who knew? Here's a little cool info some of you BMX fans will dig. Follow the PDF on Danscomp (already save the PDF!) Lose my current bearing cups to facilitate sealed bearing set up. which I plan to use, it polished up too nice not to! Stay away from square taper spindles if I plan on using my Profile Imperial sprocket. 19mm spindle, with a 22mm adapter hat since I want to use my Profile sprocket So from what I gather here then, after confirming measurements on the frame, I'll be needing: What I'm playing with here, for additional info, looks to be a 7/8" bore, 44 t, all I have is the sprocket, saw the pin hole and just assumed that I could use it on a one piece crank set if I decided to go that route. Thanks none the less for the information everybody! ![]() You'll have tight/loose spots in your chain forevermore.Īh, "Bicycle808" comes in with the answers! No offense to everybody else, just that I knew from another thread he'd messed with a Workman frame and several of the items I'm tossing around. but the only way to run a 3piece sprocket on a OPC is to bore out the hole to 15/16", and if you can't do it perfectly, don't bother trying. Oh, and Baldwooky, you can get 15/16" (aka 23.8mm) to 19mm hat spacers, to run a 1piece type sprocket on a 19mm 3 piece. on a Worksman INB.Īny other tech questions or if you need links, feel free to ask. I'm running a Profile Flywheel 44t on a 19mm Redline Flite crank. So, which crank? Any 19mm spindle will do 19mm is basically the "standard" bmx 3 piece these days, although there are 20.0mm, 22.0mm, and 7/8" spindles out there, too. If not, Profile sells them, or go with Option E from Porkchop **EDIT** porkchop doesn't have this part if you need to run a 7/8" bore chainwheel on a 19mm spindle, get the part from Profile! **EDiT OVER** **EDIT**April 2017 the url for the 7/8" to 19mm hat spacers is now **EDiT OVER** You'll want to measure carefully before you line everything up, as frequent rebuilding of most BMX cranks leads to the splines wearing down on the spindle.įWIW, a sprocket like the Imperial is not meant for square taper cranks, and won't work on any. If the Imperial has a 7/8" bore, you'll need a 7/8"-to-19mm hat spacer, which likely came with your sprocket. at any rate, don't cheap out! Definitely get a sealed one) and any BMX-style 3 piece crank with a 19mm spindle. In either case, you'll want to get an American BB set for 19mm cranks (You can spring for a Profile or Redline makes a good one for cheap. Depending on the vintage, your Imperial will either have a 7/8" bore or a 19mm bore. If you wanna run a Profile Imperial, I'd STRONGLY advise against going with a euro adaptor you won't need it. Hopefully somebody can shed a little light on this conversion, again this is going on a Workman frame but I think my confusion would translate to other 26" cruiser frames. I browsed the "How To" section but didn't find anything specific and I' know it's been done quite a bit. I get that some of the spindles are square taper or splined for the crank arms, again though, no size references beyond the crank arm? What are the items of concern when going this route (1 to 3 crank conversion)? Obviously BB size is an issue but typically the only measurement I seem to be seeing is the crank arm length. I don't know squat about BMX bikes, which most three piece crank sets I'm seeing are referred to. Now the problem is the sprocket won't fit a one piece crank set (at least none that I have on hand) and hopefully I don't have to go with a Profile crank set up based on the pricing I've seen. Hopefully "Bicycle808" is reading, apparently done some updating stuff to these INB frames! I'm looking at using a 3 piece crank set on the Workman INB frame, mainly cause I obtained a really nice Profile Imperial 44t sprocket for peanuts (and it's what was used on the Core 77 build that inspired the initial project). ![]() ![]() ![]() This capability curve can vary widely between laboratory and production scale. One of the boundaries of the graphical design space is the equipment capability curve or the maximum sublimation rate supported by the equipment as a function of chamber pressure. Understanding equipment capability or performance is a point of emphasis in the Quality by Design (QbD) regulatory paradigm, and has taken on increased visibility in light of the development of a graphical design space approach to optimization of the primary drying phase of a freeze-drying cycle. It is important to know which factor, or factors, limits performance, as well as the maximum sublimation rate supported by a given freeze dryer. ![]() Any freeze dryer has performance attributes that limit the sublimation rate it will support-refrigeration capacity, condenser surface area, the upper temperature limit of the heat transfer fluid circulating through the shelves, system geometry such as vapor duct length and diameter, or the dynamics of vapor flow from the chamber to the condenser. The underlying cause of the failed scale-up lot was a phenomenon known as choked flow, which we will not elaborate on here, but this event is a good example of the importance of understanding equipment capability. The failed scale-up run caused a significant delay in the product development timeline. ![]() In response to the pressure drop, the heating elements turned on again, resulting in a pressure rise to the upper limit, and the cycle repeated. As a result, the sublimation rate decreased and the chamber pressure dropped to the lower limit. When the pressure reached the upper alarm limit, the power to the heating elements in the heat transfer fluid was cut off. Pressure in the freeze dryer chamber could not be controlled, but rather oscillated between alarm limits. The scale-up batch did not go according to plan. A contract manufacturer was chosen and a scale-up batch was prepared using the suggested cycle conditions. The development scientists at the biotech company tried to take advantage of the robustness of the formulation by recommending aggressive cycle conditions that resulted in a relatively short freeze-dry cycle. It was known that the formulation itself was very robust that is, it could be freeze-dried under very aggressive conditions without compromising any quality attribute of the product, such as cake appearance, reconstitution time, recovery of original activity, or residual moisture level. At the time, the development scientists had no clear idea of where scale-up and, ultimately, production scale operations would take place. The formulation was to be freeze-dried, and formulation development, as well as early process development, was carried out by development scientists at the biotech company. Graphical AbstractĪ few years ago, a big pharmaceutical company entered into a joint development agreement for a large molecule therapeutic agent with a small biotech company. These specific procedural recommendations are based on calculations, measurements, and experience to provide useful process and equipment knowledge. Finally, guidelines for systematic leak rate testing criteria for a freeze dryer are presented. Furthermore, merits and demerits of thermal conditions maintained on the cooled surfaces of the freeze dryer condenser have been discussed identifying the specific influence of the condenser surface temperature on the process conditions using experimental data to support the guidelines. In all the guidelines provided, much attention has been paid to identifying the balance between obtaining useful process knowledge, logistical challenges associated with testing in the production environment vs that at laboratory scale, and the frequency of the testing necessary to obtain such useful information. Concerning shelf temperature mapping and equipment capability measurements, the importance of paying attention to the test setup and the use of appropriate testing tools are stressed. ![]() Specific guidelines for performing shelf temperature mapping, freeze dryer equipment limit testing (the capability curve), and condenser performance metrics have been provided. Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of the freeze dryer essential to the pharmaceutical Quality by Design paradigm. ![]() |