Old Freeze Dryer Repair or Replace?
Old Freeze Dryer Repair or Replace?
November 2003
Thomas A. Jennings
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 d
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