* * *INSIGHT * * *
Old Freeze Dryer Repair or Replace?
By
Thomas A. Jennings, Ph.D.
This is a question that in time will certainly arise regarding every freeze dryer when it becomes more than 10 years old. It is certainly not an easy question to answer and there is no general answer that will be applicable to all dryers. There are simply too many factors to be taken into account. But none the less, the question does arise on a frequent basis and it will be the objective of this issue to address the question in some rational fashion.
Given the complexity of this question I have assembled a group of experts from none other than the Surcure Company to assist us. It is hoped that through their discussions we might just be able to obtain a grasp of the scope and magnitude of the problem and the many factors that need to be taken into account.
Before we start, I think it only proper if I first introduce you to the characters, in the order of their appearance, that will be taking part in this discussion and their relative interest in the question before us. Each of the characters has an interest in obtaining an answer to our question but perhaps from a different perspective than the others.
The Novice He has appeared in many volumes of INSIGHT so he should not be a stranger to most. While his knowledge of lyophilization and the freeze drying equipment is rather limited, he will tend to rely heavily on his technical background and common sense during the discussion. He often does this with a series of questions that others find a bit irritating at times. He comes to the discussion with no preconceived agenda or any special interest in the subject.
Armondo Armondo is the Director of Validation Department and is keenly interested in the question. The present dryers are a bit of a headache for him and he is often called upon to determine if a dryer is still in compliance after it has undergone major repairs. The thought of a complete refurbishing of the dryer or the purchase of a new dryer does not thrill him for that will only add to the work load of the Validation Department. So he comes to the meeting with a bit of concern.
Jack Foresight As you might well know from reading previous issues Jack is the Production Manager for the lyophilized products. It is his task to coordinate schedules for personnel, equipment and supplies to meet ever changing needs of the marketing department. Writing a report explaining why a failure in equipment during the production of a lyophilized product did not affect its quality is a real headache but the loss of a batch of product is his worst nightmare. The constant stress of the job has taken its toll and Jack tends to lose track of small details at times. He comes to the meeting without any real enthusiasm because no matter what is decided it will certainly only complicate his life just that much more.
Mike Slick Is an operator of the freeze dryers that Jack has come to rely upon for guidance. Mike has been with the company since it was founded and gives the impression he knows the equipment just as well as the manufacturer. It is well know that Mike knows a lot about the process that is not written down and uses that information to rescue Jack from pending disaster. Although Mike is an hourly employee, still those overtime hours do mount up and one is impressed with his pay check. Being at a meeting like this is a real treat for Mike and the thought of just sitting and talking while getting paid for it is very appealing to him.
Sam Smiles Sam is the Chief Engineer of the facilities and a position that he is well suited for but also one that he seems to enjoy immensely. The reason being is that he is often the center of attention and the company relies heavily on his judgment. Since he is responsible for the maintenance of the facilities, he does not particularly like it when complex equipment like a freeze dryer malfunctions and he is called in to correct the problem. Although he will never admit it, he really has little knowledge of the lyophilization process and feels that R/D and Production often make a big deal out nothing. But he gladly attends the meeting for the prospect of purchasing a new dryer does have its appeal. The trips perhaps to foreign counties and all the friendly people he will meet who seem more than eager to please him. That Sam likes very much.
Dr. Nancy Peer Dr Peer or Peerless, as some would refer to her not too loudly, is the Director of Q/A. Her main function in coming to the meeting is that there are variations in the quality of the final lyophilized product. Although the product remains within specifications the inconsistencies do have her concerned that they could in the future experience batches that are not acceptable and she is intelligent enough to know she must go on record now warning of such a pending problem. Whether they should repair or replace the present freeze dryers are really no interest to her and she has no real in-depth understanding of the process or the equipment. All she wants is good product results.
Vice-President Sharp Mr. Sharp is a graduate of a prestigious Honeysuckle League University from which his own Father and his Father is alumnus. Never one for serious studies when he was younger because parties were much more fun, but nonetheless he was admitted to the University and never gave it a thought that the fact that his Grandfather had donated such large sums of money to the University they named a building after him. It is now know as Sharp Hall. So while Mr. Sharp may not know much about the lyophilization process or its equipment he is keenly interested on how things will affect the productivity (bottom line) of the Manufacturing Division. Given that his annual bonus is based directly on such performance, today’s meeting is of real concern. His chief concern stems from the fact that his lovely wife has learned to anticipate and has, in fact, grown to be strongly dependent on the size of the bonus. It is amazing how over the years her spending has been able to keep up with his income. So he comes to the meeting realizing that he must weigh many factors.
Miss Charm If you have met Armondo and the Novice in the past, no doubt you have also, at one point or another, met Miss Charm. She likes nothing better than to run errands for the upper management of the company. By doing so she has obtained a certain status in the company and only the foolhardy would dare raise her wrath. It is hard to tell if she brings out the worse in Armondo or he the worse in her but when they are around one another sparks do tend to fly. Now Miss Charm could get to like Armondo if he would just learn, like the others have, to stay in his place.
Just a few days have passed since the last episode (see INSIGHT Vol6No.9) and although the problems with the dryers has been on going for some time (years) it has finally reached a point where Vice-President Sharp, at the urging of Jack Foresight, felt it necessary to get all the interested parties together in one room and see if they can come up with some decision to perform a major overhaul of the two freeze dryers or replace the dryers with new equipment. So a meeting was called for this day at 9:00 a.m. in Conference Room “C”.
It is not unusual that the first to arrive is the Novice and it is rare that he is ever late arriving at a meeting. This on time nature of the Novice has not gone un-noticed and others have remarked that he would be the first even at his own funeral. So the Novice takes a seat near the middle of the conference table and just opposite windows in the room.
He does not have to wait long when the door opens and in hurries Armondo. “Where is everybody?” he asks as he drops a stack of files on the table. Taking a seat next to the Novice, he continues without giving the Novice a chance to answer, “Well how do you feel about things, should we repair those dryers or replace them?” But before the Novice can respond in walks Jack Foresight and right behind him is Mike Slick. As they take their seats opposite Armondo, he whispers to the Novice “Take a look at Mike’s uniform.” Mike is wearing a neatly pressed uniform with pleats pressed in his shirt and pants. He certainly looks a lot different than one generally sees in the production area where his uniform is anything but clean and it gives the appearance that he has slept in it for several weeks. Yes, Mike does look a lot different today thinks the Novice.
Mike is the first to speak, “You guys already for this big meeting?”
Armondo responds with “Every meeting is a big meeting, if it is worth a meeting it must be important.”
Jack is busy searching for something and asks “Has anyone seen my …”
Without even looking at him, Mike interrupts with “They are in your shirt pocket Jack.” with a patronizing tone to his voice. Jack doesn’t say a word but takes his glasses from his pocket and now looks through a stack of papers trying to organize them in some fashion.
But it is now 5 minutes past the hour and in rushes Sam Smiles followed shortly by Dr. Nancy Peer. Sam and Dr. Peer take seats opposite one another near the front of the table. The room is strangely quite as they wait for Vice President Sharp to arrive. In what seems like five hours when in reality it is just about five minutes Vice President makes his entrance. “Good Morning and I see that everyone is here and that is great to be working with such a group of punctual personnel.” He then asks “Didn’t anyone order coffee for this meeting?” as he looks at Jack.
Jack is a bit taken back and realizes that he forgot to order the coffee but before he can say anything Mike speaks up and says “Sir, it will be my pleasure to run down to Cafeteria and get you a cup. Do you take cream and sugar?”
Vice President Sharp shakes his head No and replies with “Thank you Mike but do sit down for I do want to get this meeting started. Besides I don’t want to keep you from your duties in the production area. So let’s get started with the meeting. Nancy will you please take notes of the meeting.” Nancy nods her head yes and pulls out a fresh note pad and pen and then begins to write. “Mike let us start off with you first. Tell us about what you know about the freeze dryers”.
Mike stands up and starts “Well Sir if I were to tell you all I know about those dryers we would be here for hours or even days. But if that is what you want….”
Jack tugs on Mike’s sleeve and says, “Sit down Mike and just outline some of the major problems that we have been having with the dryer. That is what Vice President Sharp is asking.”
Taking the hint, Mike takes his seat and continues in a loud voice. ”Sir there are a number of major problems with the equipment. Let me just list them for you. First there are problems with the refrigeration for both of the dryers.”
Raising his hand, Vice President Sharp says “Let us stop right there!!! Tell me what is generally wrong with the refrigeration system and can it be fixed?”
In response Mike replies “The refrigeration systems simply don’t work properly.”
“Is it because of the lack of maintenance that they are not functioning properly? Asks Vice President Sharp with a serious tone to his voice.
Mike is quick to respond for he can feel that Sam Smiles is staring at him rather intently. “Absolutely not Sir, those machines have received the finest maintenance that money can by. No question about that Sir!!”
“Well then” continues Vice President Sharp “if they are maintained so well then how come there are problems with the equipment?”
There is a deadly silence in the room as Vice President Sharp waits for an answer. The Novice breaks the silence by asking “How old are these dryers?”
Mike responds “I was just new with company and I helped with their installation.”
It was Sam who gives a more definitive answer with “The dryers are 15 years old and they still have the original compressors. The fact that they are operating about five days every week means that they have seen a lot of service.”
Vice President Sharp responds with “But my Mother has a refrigerator that has to be more than 20 years old and it is still going strong so why should there be a problem with these refrigeration systems that are just 15 years old?”
“But your Mother’s refrigerator does not run continuously for days on end. If it did your mother would have had to replace the refrigerator well before now.” Is Sam’s response to the Vice President.
Vice President Sharp is now starting to show signs of losing his patience. “Ok, I understand that but what is wrong with the refrigeration system that we here are trying to determine if we should repair it or replace it. Will someone please enlighten me on that question.”
It is Armondo who now speaks up for the first time. “Sir, our records show that the problems are not one single problem that I am sure Sam could fix right away but a series of small problems that can be fixed but there is often an interruption in the manufacturing process. My assistant and I have made a list of such incidents requiring the attention of the Validation Department for just the last six months and one can see the number of incidents is quite considerable.” Armondo then hands the list to the Vice President.
While the Vice President is glancing at the list, Dr. Peer asks “Could such frequent interruptions to the process cause variations in the final product from batch to batch.”
“Why yes.” says Armondo..
“How?” asks Vice President Sharp.
“How?” responds Armondo with a bit of a surprised look on his face.
“Yes how?” a determined Vice President responds.
Seeing that his friend is in a bit of trouble, the Novice speaks up and says “A brief loss in refrigeration may cause a momentary increase in chamber pressure that affect the product temperature but the product temperature is still within the limits established during validation of the process. So while the product may be acceptable, none the less the scatter in the data gives Dr. Peer reason to be concerned about when future batches may not be acceptable.”
A now more confident Armondo adds his support by saying “We do not want to cause Dr. Peer to be concerned.”
“So I see” replies Vice President Sharp. “Our first task will be to perform cost analysis for the replacement of the refrigeration system. Sam will you give us an estimate on the cost of replacing the refrigeration system and the down time for the units. Jack based on the down time give us an estimate of the loss in production units and I will take it from there. If that is the only thing that is wrong with these units I think we can now put an end this meeting.”
Mike felt he had not made a good enough impression and so he speaks out with “Sir there is a lot more wrong with the equipment. In fact there are malfunctions that never get reported and would have resulted in possible loss of product had the operators not used their ingenuity to correct the malfunction.”
With a bit of a grin on his face and a look of concern on the faces of the others, Vice President Sharp asks “Tell me more about these additional malfunctions that go unreported.”
“Well Sir” begins Mike knowing he is now the center of attention. “as an example let us take the case of the gate valve.” At the end of the freezing of the product our instructions call for us Operators to open the gate valve when the condenser has reached -60 C or lower. Now we have found, that when we go to open the pneumatic value that is an air operated valve
“I know that a pneumatic valve is one which is air operated” injects the Vice President.
“Very good Sir for I did not want to confuse you with my use of technical terms.” Replies Mike and continues with “When we Operators go to switch open the pneumatic gate valve between the drying chamber and condenser chamber it does not work. Now I ask you, should we wait until maintenance comes to try and fix the problem? We Operators have found a way to open the gate valve so that there is no deviation in the procedure and we don’t have to bother the maintenance personnel.”
With his chin being supported by his right hand, Vice President Sharp asks with now a bit of a smirk on this face. “And just how do you go about solving this problem?”
Jack buries his head into his hands; Sam looks out into empty space while Armondo and the Novice sit there as if they are spell bound. Only Dr. Peer is too busy taking notes to be aware of what is going on around her.”
Knowing that he has everyone in suspense he answers “We give it a good whack with a hammer Sir”
Sam suddenly comes out his trance and says “You do what?”
“I just told you Sam, we give it a whack! Repeats Mike.
The Vice President is trying not to laugh but has to offer some help to Mike by saying “Not just a whack but a good whack is that right Mike!”
Feeling that the Vice President has been duly impressed, Mike relies “You are so right Sir a good whack.” Feeling that he has everyone’s undivided attention, Mike continues with “and I bet you can’t guess how we get the gate valve to close?”
“Don’t tell me let me guess.” Answers a smiling Vice President Sharp and continues with “You just give the valve a good whack!”
“You are so right Sir, we gives it another good whack and down she goes to close.” Responds a self satisfied Mike.
Jack refuses to look up but just stares at the table.
It is then Vice President Sharp asks Jack “Where you advised of this wacky procedure?”
Jack has trouble finding the right words but no matter Mike helps him out with “No Sir that procedure was entirely the idea of the Operators and I might just add, in all modesty, mainly my doing.”
At this point Vice President Sharp tells the group “I think we have learned enough for one day.”
But Mike feels he has still much more to say and quickly replies. “But Sir you have not found out how we Operators fix the problem with the process control system. You would never believe what we do to get that system to work.”
But the Vice President has had enough for one day and replies “I will be in touch with you when we can continue this meeting.” He no sooner finishes when there is a knock at the door and he shouts ‘Come in!”
The door opens just a little and a head peeks in and says in a soft voice “Vice President Sharp, please excuse me for interrupting your very important meeting but I do have a rather urgent message for you. It is from your beautiful wife” It is none other than Miss Charm.
Vice President Sharp motions her to come and says “Yes, I will take the message and we are done here for today.”
Miss Charm gives him the message and stands next to him as he reads it. “Will you wish me to reply to her Sir?” asks Miss Charm with a soft voice.
“No! I will take care of this matter myself” is the response.
As Vice President Sharp confers with Dr. Peer about the notes that she has taken, Miss Charm starts to leave the room but can’t resist walking by Armondo and giving him a look of distain. Given how Miss Charm treats him when she comes into his office and her disdainful stare, Armondo feels compelled to say something. As usual he makes a poor choice of words by saying “How are the headlights today?” (please see INSIGHT Vol. 6 No. 9)
Now we all know that Armondo is referring to the headlights of her car. But you must also be aware of the fact that nature as been very kind to Miss Charm and she is envy of many of the female employees but the delight of most male employees. It is also in her nature that if she can misunderstand something, especially if it comes from Armondo, she will surely do it. That is why she stopped in front of Armondo and in a loud indignant voice say “What did you just say?”
Suddenly all eyes are on Armondo as he tries to find the right words but his bright red face tells the tale. Not giving Armando a chance to respond, Miss Charm warns “Watch it!!!” and leaves the room.
Vice President Sharp is the first to speak and asks the question on the minds of many others in the room. “Armondo what on earth did you say to her?”
Still in a rather confused state Armondo blurts out “I just said “How are the headlights today?”. That’s all I said to her and nothing more.”
“That is all?” repeats Vice President and everyone except the Novice start to laugh. Even Dr. Peer finds it hard to reframe from grinning. With this Vice President Sharp gets up and starts to leave the room but must first stop by Armondo and with a hand on his shoulder say “That took courage my boy. That took real courage!!”
“But her headlights did go out Sir” Armondo tries to explain.
This only causes more laughter and Vice President Sharp leaves the room without saying another word.
In a low voice, the Novice just says “Let’s go and get some lunch”.
At lunch Armondo is still very upset with what happened with Miss Charm so the Novice tries to get his mind off of it and on to something else. “What do you think? Do you think we will end up purchasing a new dryer or repairing the old dryers?
Armondo thinks for a moment or two and now he starts to forget his brush with Miss Charm. Finally he answers with “I really don’t know how it will go for it is tough question to answer. Clearly we have to do something with the refrigeration system and the data collection system is outdated and should be replaced. Given those two factors alone I would suggest that we purchase new equipment. Don’t you agree?”
Nodding his head to indicate agreement, the Novice responds by say “I tend to agree with you that it be best to replace the refrigeration system in both dryers. I also agree with you it would be imperative that we replace the process control and data collection systems. One can only guess from what we heard today what abuse they have suffered. We certainly need a tamper proof system control and data collection system. But based on my analysis I would repair dryer #1 and replace dryer #2.”
Armondo is puzzled by what he just heard and asks “Tell me why you would repair one and replace the other. Were they not both purchased at the same time and from the same manufacturer?”
What you say is true Sir.” Is the Novice’s response and he continues. “But keep in mind that is 15 years ago and time and heavy usage has taken their toll. Let us in general consider the condition of each dryer.
“Sound reasonable to me” replies Armondo “So do continue starting with Dryer #1.
“I will but first let me ask you a series of questions.” The Novice responds.
“Fine!!!” says Armondo eager to voice his opinion.
And so the Novice begins with the first question.
“How would you rate the condition of the drying chamber as a pressure coded vessel good fair poor.”
“I would say that chamber is still quite sound so I would say it is still in good condition.” Armando replies.
“Any problem with steam sterilizing the chamber or major real leaks?” is the next question.
“We did recently have a leak in the gauge connection with the chamber and it took days to find it. That leak almost did Jack in” replies a smiling Armondo.
“But the leak was because the gauge connection was not connected properly and we had trouble getting a vacuum sufficient enough to keep the door closed. That was no malfunction or defect associated with the chamber just someone over tightening the gauge connection that was the cause of that problem.” Is the responce given by the Novice.
Armondo thinks for a moment and replies “That is quite true and we never did find out who did it.”
With a wave of his hand the Novice continues with “You will never find out and there is no sense being concerned about it at this point. Now let me continue with the shelves. Are there any problems with the shelves that you know of?”
“The shelf surface is fairly scratched up and we did have that problem with the stoppers sticking to the upper shelf but other than that our testing still show that the temperature distribution across the shelf and from shelf to shelf are about what they were when the system was new. So all in all I don’t see any real need to replace the shelves at this point.
The Novice then asks “What about the Stoppering system?”
“No real problem with the system as I see it except we did have to replace the hydraulic pump once.”
The Novice continues with, “What is your overall assessment of the chamber? Do we really need to replace it at this point and what would be your estimate of its useful life at this point”
“I would say the dryer chamber should have an expected life of from five to ten years. But the condenser chamber is another story.” Is Armondo’s response to the Novice.
“But you have forgotten one important component.”
Armondo is thinking hard to reach an answer so the Novice helps him out with just two words “Gate valve”.
With his face having a big smile, Armondo shakes his head and says “You have to replace the gate or whatever is left of it before it won’t open or close one of these days.”
The Novice also smiled and then replied “Now what about the condenser system?”
“Well”, said Armondo, “based on what you have said about the drying chamber, the condenser chamber is in fairly good condition. But there is a constant problem with one of the condenser coils not being able to get cold enough. So I think we should replace the condenser.”
“But”, replies the Novice “that is not the fault of the chamber but the refrigeration system and since we already agreed on what to do there, we can replace the entire condenser system.”
“Can I ask just one thing” say a serious Armondo. “Can you put in new windows in the condenser and drying chamber because it is difficult to see inside.”
‘Sir”, I think that can be arranged but what about the pumping system?” is the next question.
“I think we will need new pumps because these pumps seem to collect a lot of water. “
“True”, says the Novice, but that is a result of the problem with allowing water vapor to pass by. So we should check those pumps out before we make any decision. Now let me ask the following three simple questions about dryer #1.”
“Does the dryer pose a safe environment for these facilities?”
“Why certainly it does.”
“Does it pose a safe environment for the operating personnel?”
“It certainly is safe for personnel to use but is it safe from the operating personnel is another story at this point.”
“Now, one more question” continues the Novice. “does it provide the necessary operating conditions for the lyophilization process?”
Armondo thinks for a few moments and not quite sure of himself, replies “I am sure if we replaced the refrigeration system and the process control and data collection system it would work fine?
“Now’, continues the Novice “using the same last three questions how would you evaluate dryer #2?”
Armondo shakes his head and replies “I think it is safe for the facilities but when they steam sterilize it, well, it looks like it going to blow up at any moment and frankly I get nervous just being around it.
“Now for one last question.” asks the Novice “How do you feel about dryer #2 being able to provide the necessary parameters for conducting the lyophilization process for Surcure?”
“Well” says Armondo thinking out loud, “I would say marginal at best right now. No doubt that is what has been bothering Dr. Peer and she has not seen the connection between the dryer and the performance of the product. I think that would be something for me to check with her about. She might well provide us with some real data to support our feeling.”
“So your overall evaluation of this system? Should we repair dryer #2 or replace it?”
Armondo has to smile and then says “I say replace the unit as soon as possible. It is just not worth the time and resources to fix it up. Tell me why didn’t you bring this up at the meeting that we just had?”
The Novice just smiles and says “I just think you can do a much better job than me at the next meeting.”
With a thoughtful look on his face, Armondo responds with “Perhaps you are right I do have a way with words.”
Placing his hand on his friend’s shoulder, the Novice says “You certainly do have a charming way with words. Hey, we better get back for we do have more work that needs to be done to prepare for the next meeting.”
Armondo responses with “You are right, you are so right.”
Acknowledgement: I wish to take this opportunity to thank Idania Caballero Torres for suggesting the topic this INSIGHT. If you also wish to thank Idania then you can do so by sending her an e-mail at idania@ict.cim.sld.cu.
Volume 6 Number 10 November 2003
