We aim to be your consulting resource in freeze drying. Whether you are seeking support in Advocacy in having us act as your experts in Factory Acceptance Testing, or Site Acceptance Testing, providing Expert Advice, or acting as your agent for supplier negotiations, we will help you get the job done. We have years of experience in all of these roles in the world of freeze drying. Practical knowledge and experience guides us to perform in your behalf. Applewood Scientific also conducts seminars at your facility on fundamentals of freeze drying, validation of freeze dryers, and maintenance.
There are many paths that lead to a success one may consider the following:
URS to Process envelope correspondence: Start the process of obtaining a freeze dryer knowing what the product characteristics are, and then dictate specifications and a URS that reflects the hardware, software, performance envelope that will provide the least risk. Write the specs so that the resultant machine ensures that the product can be successfully processed in this dryer, as specified in the URS. If you are not able to do this with in-house expertise, allow Applewood Scientific to assist you in this important starting point.
Evaluating vendor quotations: resulting from a URS is the next step, usually taken. Responses have different foci and strengths and weaknesses which must be resolved against your URS. This task requires expertise, communication for resolution. Again Applewood can assist you in this program to ensure that you have a fuller understanding of all offerings before a choice is made.
Once the choice is made: Approval for manufacturing, confirmation of the vendor kickoff document [the response of the vendor that sums up what they will build] and the manufacturing process continues. Once the system is completed [in all phases, including documents for FAT, SAT, IQ/OQ/CSQP, instructions, P&ID’s, electrical drawings, certification of materials, calibration documents from sensor manufacturers, as well as vendor cut sheets for each component, spare parts lists for 2 years of operation] the FAT can be scheduled and completed. Completing the FAT successfully takes a concerted effort to go over each and every detail before the machine is shipped, and before leaving the factory it is your responsibility to ensure that every detail is confirmed. Negotiating with the project team to resolve all outstanding items, leaving those with little risk to successful completion to be done in the field, are typically completed, before you provide your final commitment. Applewood Scientific is available to assist you in all phases of this program.
After shipment: The installation process begins with system placement. This is a risk filled endeavor, requiring a keen eye for hidden damage. There are potential time sensitive insurance claims that may need filing and documenting. Afterwards installation needs to be completed including supervision of riggers, leveling, faring into the clean room wall, and sealing the sterile loading and mechanical spaces properly to avoid leaks that may compromise integrity. This may require special sheet metal work.
The installation: which involves reconnecting the system to services, or reconnecting heat transfer and refrigeration piping, leak checking, and many other activities requiring specialized knowledge, expertise, and technology to ensure that the system will begin operation without incident. Any synergistic effects of many subtle issues are elucidated and resolved.
After installation: and startup the SAT, IQ, OQ [Validation] are completed. If these procedures were completed at the factory before shipment one may make risk based decisions as to which can be leveraged and which must be repeated at your facility.
After these activities the PQ can be completed: Media fills are completed ensuring that all activities, training, and quality assurance programs fit seamlessly and that batch records are able to be stored securely, typically choosing and running the recipe that will most likely produce an acceptable product is next. The next activity is providing assurance that this program and product requirements are met. Perhaps operating with a placebo, or choosing the right way to evaluate product success, is implemented. Next, choosing and executing accelerated and long term stability test programs, CIP and SIP evaluation, and in process analytical analysis, and meeting release criteria, may be activities that are completed.
Applewood scientific can be your resource in implementing all or a select few of these activities