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Cleaning A Vial Filling

Operator attention to detail and adherence to cleaning procedures are crucial for proper cleaning of vial filling lines. Strict standard operating procedures and robust training are needed so that operators understand how to properly clean the lines and facilities. When changing products on a line, it is important to thoroughly clean the line after each fill to prevent dried product, and to properly dispose of any remaining product or waste before switching. Beginning cleaning from the cleanest to dirtiest areas and thoroughly removing all traces of the prior product are best practices.

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22 views

Cleaning A Vial Filling

Operator attention to detail and adherence to cleaning procedures are crucial for proper cleaning of vial filling lines. Strict standard operating procedures and robust training are needed so that operators understand how to properly clean the lines and facilities. When changing products on a line, it is important to thoroughly clean the line after each fill to prevent dried product, and to properly dispose of any remaining product or waste before switching. Beginning cleaning from the cleanest to dirtiest areas and thoroughly removing all traces of the prior product are best practices.

Uploaded by

rouss1906
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Cleaning a Vial Filling Line

Operator attention to detail and adherence to procedures are crucial for


proper cleaning.
Sep 02, 2015
By Jennifer Markarian
Pharmaceutical Technology
Volume 39, Issue 9, pg 58
Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile manufacturing process,
including vial filling. In addition to having procedures, the operators on the line who are performing
cleaning tasks must understand the procedures, grasp the importance of their tasks, and do their
jobs well.
Grand River Aseptic Manufacturing (GRAM), a parenteral contract manufacturer, operates cGMP
aseptic and sterile vial-filling lines for both liquids and lyophilized drug products at two facilities in
Grand Rapids, MI. Alex Fox, an experienced operator, and Jason Steele, operations liaison, both at
GRAM, spoke to Pharmaceutical Technology about the challenges and best practices in cleaning a
manufacturing facility and a vial-filling line in particular.
Cleaning best practices
PharmTech: What are important aspects of and best practices for cleaning in a pharmaceutical
manufacturing facility?
GRAM: Strict adherence to standard operating procedures (SOPs) and a training program are
crucial. SOPs are in place so that different operators can complete a task in a consistent manner.
FDA expects written SOPs detailing the cleaning process. GRAM's SOPs outline each step so that
personnel can synchronize and work as a team. A robust training program is required so that
operators understand the importance of following procedures as well as the importance of keeping
the facility clean.
In addition, it is crucial to document all activities for cleaning. Lack of documentation or
documentation errors can potentially create equipment downtime and negatively impact efficiency.
All personnel must understand why cleaning the facility in the correct order is a best practice.
Personnel must first clean the more strictly controlled cleanrooms, which have a higher
classification, before proceeding to rooms of lower classification. Cleaning in the incorrect order can
be a significant risk to sterility assurance and may create cross-contamination between classified
areas.
Attention to detail and ensuring that sufficient time is allotted for cleaning to be a priority are also
important. Cleaning should never fall behind due to other tasks, and its importance in aseptic
operations should never be understated. Although cleaning can be mundane, extreme focus is
necessary for cleaning to be completed correctly in pharmaceutical facilities.
Cleaning between products
PharmTech: What are the key steps to cleaning a vial-filling line when changing from one product
to another?
GRAM: Performing a post-fill cleaning of the line immediately after a fill is completed is crucial
because it ensures that the product does not become dried onto the line. It is also important to
ensure that the appropriate cleaning methods and tools are used so that no product is left after
cleaning is completed. Different products may require different procedures.
Proper disposal of any and all rejects, tailings, and any other drug product left in the room is crucial
when changing from product to product. An operator must ensure that all substance is removed
appropriately. Proper disposal ensures cleanliness and operator safety.
Another tip is to begin with the cleanest equipment and move to the dirtiest area within a room. For
example, begin with the fill line and, subsequently, the inside and then outside of a restricted
access barrier system (RABS) if applicable, followed by the ceiling, walls, and floors.
To have the room released for the next fill or client, an operator’s top priority must be proper line
clearance by removing previous product and cleaning equipment. An operator must remember that
cleaning the equipment and removing all drug substances are both equally important when
preparing to switch between products.
Cleaning validation
PharmTech: What are some of the challenging aspects of cleaning validation for a vial-filling line,
and what are the best practices to solve these challenges?
GRAM: A challenge is the time and resources required to perform the cleaning validation for a vial-
filling line. It is important to optimize procedures and the use of resources, as well as to stay up to
date with any new trends in the validation sphere. For example, GRAM is implementing disposable
equipment, which can reduce cleaning and cleaning validation requirements.
Ensuring aseptic processing conditions
PharmTech: In addition to cleaning and cleaning validation, what else is crucial to ensuring aseptic
processing?
GRAM: It is also important to have qualified sterilization methods for bringing components,
materials, and equipment into the cleanroom. Autoclaving all components and equipment allowed in
the cleanroom, for example, is a straightforward method.
At GRAM, we believe that the following are crucial to ensure aseptic processing:

 Proper training. The manufacturing crew must be trained, qualified, and most importantly, be
comfortable in gowning, personnel monitoring, environmental monitoring, and aseptic
interventions.
 Personnel working together. At GRAM, we make sure that our manufacturing crew and quality
assurance (QA) team operate as a unit in the aseptic processing areas.
 Continuous improvement. The manufacturing and QA crew participate in 'lessons learned'
sessions to review batch trending, for example; the ideas discussed in these sessions have
been implemented, resulting in improvements and greater efficiency.

Article Details
Pharmaceutical Technology
Vol. 39, No. 9
Page: 58
Citation: When referring to this article, please cite it as J. Markarian, “Cleaning a Vial Filling
Line,” Pharmaceutical Technology 39 (9) 2015.

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