Setting up a pharmaceutical cleaning strategy

Cleaning is an essential practice for any pharmaceutical activity. Difficulties can arise from the fact that the concept of ‘clean’ is not easily defined or can be related to non-evident residues.

 

Defining differences between sterilization and cleaning treatments, for example, is important to understand in-depth the main problems and peculiarities when setting up a cleaning strategy.

 

The kinetics of ordinary sterilization processes are well understood: to sterilize means to destroy or inactivate microorganisms. In this perspective, we know the target and we can define it in terms of a number (CFU/unit) and resistance (D, z). Though the definition of sterile product/ item is probabilistic (PNSU – Probability of Non-Sterile Unit or SAL – Sterility Assurance Level), it is universally accepted.

 

On the other hand, for a cleaning process, the “enemy” is not defined and, in any case, can vary on a case-by-case basis: residue of previously processed product, diluents, solvents, lubricants, microorganisms, etc. There is no absolute definition of cleanliness. The kinetics of the cleaning procedure are unknown. Consequently, also the definition of “cleaning dose” to be provided is undetermined.

 

In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated. FDA inspectors have to assess the rationale used to set the cleaning limits, making sure that their basis are scientifically justifiable and grounded on adequate knowledge of the materials involved.

This is the reason why Fedegari have published a new e-book: to discuss the main challenges on taking the right decisions while developing a cleaning strategy. New requirements have been faced by manufacturers, new targets have been fixed and the evidence that these are met is shown through successful case studies. Our aim was to highlight the best practices and existing solutions to support your decision-making.

This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Fedegari have collected contributions of all these areas together in order develop a robust and repeatable cleaning process.

In their new E-book you will find:

  • Aspects Distinguishing a Cleaning Process
  • Steps for Setting Up a Cleaning Procedure
  • Case Study I: Removal of Bacterial Endotoxins
  • Case Study II: Application of a Washer Sterilizer
  • Case Study III: Soil Removal From Smart Plate

 

Download it here for free. If you want to discuss your cleaning strategy with us give us a call at 800-829-5741.

 

 

Complete Production Line by Cozzoli

On specific client demand, Cozzoli has developed a complete production line that houses Filler, stopper, capper and unscrambler. The complete production line was installed at Biocor in Omaha, Nebraska. This is a very comprehensive production line solution since it meets all the FDA regulations regarding vaccines for veterinarian use.

 

OPERATIONAL LINE SEQUENCE:

Containers are placed on the unscrambling table, where they are automatically fed into the filler infeed conveyor. The containers are allowed into the filling station by a gating device, adjustable for different container sizes. After completion of the fill cycle, filled containers travel to the RS400 Stoppering Station, where full stopper insertion occurs. After stoppering, containers then travel to the CM200 Crimping Station, where aluminum crimp seals are adhered.

 

Containers enter the filling machine via the gating device and are filled using the diving nozzle system. The VR840 is a positive displacement liquid filler, operating on a 4″ pump stroke. This filler is equipped with a total of 8 stainless steel syringes for fill volumes up to 600 ml, and speeds up to 120 bottles per minute. After the fill is complete, containers cycle out of the filler and enter the Stoppering System.

 

BioCore’s RS200 Stoppering System is comprised of a vibratory sorting bowl, stopper feed chute, container feed screw and stoppper pressing foot. This machine is stoppering three container sizes with 20mm and 30mm stoppers. Sensors are located on the stopper chute for stopper make-up and on the conveyor for container make-up and back-up.

Traveling down the conveyor, the filled and stoppered vials are captured by an infeed starwheel for entry into the CM200 continuous motion rotary crimping machine. This machine also has a vibratory bowl; orienting the aluminum caps for placement into the feed chute. As the stoppered containers pass underneath, the containers strip-off the aluminum cap as it enters the infeed star wheel. The container then passes into the main star wheel, where the crimp head lowers. Contact with the cap activates the crimp head rollers to begin the progressive roll seal process.

CRIMPING OPERATIONAL SEQUENCE:

A fixed cup is used in each crimp head to prevent rotation of the container, and the crimping skirt height is easily adjusted for each size crimp. An automatic vial height adjustment is included with this machine for ease of container changeover. Simply place the container on the height gauge, and the height is measured and corrected automatically on the crimper. This machine will crimp 20 and 30 mm seals.

Pentafill A25 on exhibit at Packexpo 2018

Stop by LF of America’s booth at this year’s Pack Expo in Illinois to see the Lameplast Group state of the art machine in the single dose units filling and packaging. Not only can the Lameplast Group boast an original pack, but also innovative filling technologies, now specifically conceived for sterile filling.

Top of the range is the brand-new model Pentafill A25 that was unveiled in November 2017. It is an automatic filling and sealing machine specifically designed to work in a sterile environment, capable of processing single-dose capacities from 0.3 ml to 10 ml for medium production runs. Versatility is a key feature of this machine, as matter of fact it can be easily connected to any existing packaging line. Moreover it is suitable for small rooms and very easy to maintain. It could incorporate a laminar flow system to ensure sterile filling during operation, as in the new Pentafill A15L.

The Group can today offer its customers seven types of semi-automatic or automatic single-dose units filling and sealing machines, ideal for small and medium productions. All seven models are available in a standard version but may also be adapted and customised as desired. Thanks to its high technological knowhow and the possibility of tailor-made solutions, Lameplast group can satisfy the needs of demanding customers worldwide.

LF of America will be setting base at Booth: W-879 and the Pentafill A25 will be displayed and set to be in operation for Demo Purposes. Interested in scheduling a meeting with some of LF’s product specialists during the expo, just give us a call and we’ll set a meeting on the agenda.

Fedegari Published New Case Study

Fedegari Technologies’ latest case study, “Berkshire Sterile Manufacturing: Flexible Clinical Scale Aseptic Filling System”,  has been published in the printed edition of “Cleanroom Technology” Journal.

[pdf-embedder url=”http://lsi1.com/wp-content/uploads/2016/12/Fedegari-Case-Study-Sterile-Filling-2016.pdf” title=”Fedegari Case Study Sterile Filling 2016″]

New Fedegari White Paper

Fedegari conducted an R&D study that has been presented at the 2016 PDAA Universe of Pre-filled Syringes and Injection Devices, in California. Developed in collaboration with IBSA Farmaceutici Italy and Amphenol (Kaye), the study has now been transformed in a white paper, “An Innovative Way To Sterilize Hyaluronic Acid PFS.”

Check it out in Fedegari’s Website: http://www.fedegari.com/en/an-innovative-way-to-thermally-sterilize-hyaluronic-acid-pre-filled-syringes/

Torqo Calibration White Paper

Overview
The Torqo instrument uses two calibrated spring beams and a very precise rotary position
encoder to read the applied torque. Calibrating the Torqo machine is done to linearize the
response of the spring beams. After calibration is completed the rotary position of the
main shaft will correspond to a reading of the applied torque that is accurately referenced
to a traceable standard.

 

Factory and User calibration
Calibration is always done at the factory using NIST traceable standards. The Factory
calibration is accurate at the time the instrument is shipped and for 1 year following.
Re-calibration may be done by the end user at their own specified interval with their own
weights. The user always has the option to apply the results of their own calibration or to
switch back to the Factory calibration values.
Factory calibration is typically done at 7 values of applied torque that span the range of
the specific instrument. Those values are 0%, 10%, 25%, 50%, 75%, 90% and 100% of
the torque range of the instrument.
User calibration is typically done at 4 values of applied torque that span the range of the
users instrument. Typical values are 0%, 25%, 50%, 75% and 100% of the torque range of
the instrument. Users may add their own calibration points i.e. 12% if desired, provided
they have the required weights. Note the 100% weight is usually achieved by hanging the
25% and the 75% weights together. Note the process of user calibration disables factory
calibration so the actual vs. ideal curves can be created and compensation is not done
twice.

 

Compensation and Interpolation
The instrument uses the calibration readings in both directions, clockwise (CW) and
counterclockwise (CCW), to create two compensation tables which correct the actual
readings and result in accurate torque readings traceable to standards.
The calibration weights only cover discrete points throughout the range of the instrument.
These points are shown as data points in the accompanying graphs.
To calculate the compensation required for measured torques that fall between these
discrete points the instrument used linearly interpolated values for the torque
compensation which falls at points between the measured calibration values.
These interpolated values are shown as thin lines in the accompanying graphs.

 

Charts
The charts below show sample compensation data for a customer’s machine. The
difference between the ideal and actual is stored and used to compensate all readings and
results in linear, traceable, accurate torque readings.

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Click here to see more at: http://torque.mesalabs.com/wp-content/uploads/sites/4/2013/11/Torqo-Calibration-White-Paper.pdf

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