Archive for category: General

It’s natural to get comfortable in your job role once you have been employed by a company for a certain amount of time. You have learned the ins and outs of your role and responsibilities and mastered your niche in the company.   Most of us seem to be happiest when we have found this comfort zone at work, when our confidence is high and we have a strong sense of control over the things around us.   However, this can also mean that you have stopped growing professionally.  If your career growth remains stagnant too long you may see your peers and your profession pass you by.

In today’s market place it is critical to always be looking ahead at what might be expected of you for your next assignment. Without professional development you may not be marketable in the near future.   The idea of having to re-invent yourself is intimidating to most people, but may be necessary more than once for continued growth and a successful career. This can best be achieved by creating your own professional development strategy and setting your own goals.

The best way to approach professional development is to take charge of it yourself. After all you are doing this for you. More often than not professional development activities can cost the company money, but prove beneficial in the long run.   By taking the initiative and providing a detailed and well thought out plan to strengthen the company by cultivating talent you give yourself the best chance at the best opportunities.

There are many ways to achieve your goals of professional development.   Start by addressing and improving your personal weaknesses. It’s a good idea to improve your organizational skills, be more effective at meeting deadlines, or learn to prioritize more efficiently. Improving these skills will increase your value and make you more marketable regardless of your field.

Next, try to find someone within your company who’s not only willing, but also interested in helping you by offering guidance and advice. Having a more experienced senior co-worker to run ideas by can help making the right decisions much easier. Taking a course related to your job or what you would like your job to be in the future is simplified in this day and age. Most schools now offer on-line courses that can be taken at your convenience and around your schedule. If you can’t take a course, conferences are not only great for learning but also for networking. Find the conferences that are most applicable to people who work in your industry and go. Not only will you learn about new techniques, skills, and industry standards within your profession, but you’ll also make new contacts with the same interests. New contacts within your field have the potential to be invaluable assets to your career growth. You never know where someone you know may end up in the future and what opportunities they may offer you as a result of your relationship with them.

 

Written By: Nate Roberge, Consultant II

ICQ Consultants, Corp.

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.

Temperature Mapping is the process by which an entire area of an environmental chamber is continuously monitored, recorded and analyzed over a predetermined amount of time under real operating conditions.  Environmental chambers vary from cryogenic freezers and incubators to refrigeration trucks.

The temperature across all areas of an environmental chamber will not usually be uniform and will vary to a certain degree. Possible areas that could vary in temperature could be near the door, on the wall, below the compressor area or near a fully loaded rack versus an empty rack.

In all such conditions, hot spots are created and could potentially affect product quality. In some cases, areas of the chamber that are too cold can have adverse effects on product quality.  Environmental chambers that cannot maintain the correct temperature ranges could cripple or damage a product and then halt the production of said product.

The solution for this is to execute temperature mapping qualification written and designed for environmental chambers. Testing should be completed for both an empty chamber and when the chamber is loaded with the appropriate product placebo (perhaps several loaded chamber qualifications if your chamber stores a variety of products).   Also, it is recommended (depending on your geographic location) to perform a qualification/re-qualification for the location of storage for refrigeration trucks during both the hottest and coldest times of the year. This would ensure that your environmental chambers are fully qualified for product storage and safety.

 By:  Tony Puleo, Consultant

ICQ Consultants, Corp.

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.

All too often otherwise successful projects in the GMP space encounter scheduling and compliance challenges for a simple reason: A failure to properly integrate Quality Systems and compliance requirements into the project planning effort. Complex build outs, engineering efforts and process changes can all fall flat in the final hour for these simple reasons. There are few things more frustrating than completing months of technically challenging work on budget and on schedule only to see the project slip because a quality record was not in the correct state or a required reviewer was missed.

So what can firms do to avoid this frustration? How can we ensure success in meeting timelines, accounting for the final 2-5% of the project effort? The answer is to integrate the quality systems into the project from the earliest stages. This answer seems simple, but requires a dedicated effort and the right people to be involved at the right time throughout project planning and execution.

Starting with early design and engineering, seek out quality representatives to begin assessing impact, determine system criticality and related documentation requirements. As the project progresses to planning and execution, consult Quality Operations units ensuring the right resources are informed and consulted. Identify clearly the quality system requirements and associated timelines, integrate these as deliverables and milestones into the overall plan and schedule. Keep lines of communication open with Quality as project variances will inevitably occur, adjust not only the technical side of the project plan but the associated quality system and documentation requirements. A consistent integrated approach ensures compliance, timely project completion and eventual turnover.

There always seems to be a segmented approach to project planning in which quality system efforts are considered a final stage, when in reality a proper integrated approach is the best way to ensure compliance. Navigating and understanding quality requirements early and often is critical to project success in the cGMP space.

ICQ Consultants offer a wealth of experience from early design, engineering, construction / execution, and quality system management. Our goal is always to understand the many aspects of a project and integrate all phases to ensure success, avoiding the dreaded delays after months of successful execution. Please reach out to our management team to find out how we can support an integrated project plan for your next effort.

By:  Michael Olival, Managing Consultant

ICQ Consultants, Corp.

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.

ICQ Consultants is looking to hire dedicated professionals in the MA, NJ and PA areas. ICQ is
one of the largest and most sought after CQV suppliers in the Northeast and we have expanded
with offices in the Southeast as well. We are seeking to hire mid to senior level Validation staff
that are Subject Matter Experts (SME) in Clean in Place (CIP), Steam in Place (SIP) and
Environmental Monitoring.

Integrated Commissioning & Qualification, supplies services in the life science industry. Our
services range from technical commissioning and qualification engineers to project management
services. We focus on the commissioning effort in alignment with qualification, which can
leverage man aspects of those efforts with complying to procedures and quality systems.
Our company provides some of the most competitive benefits and wages in our segment of
service provider which include the following:

• Tufts Health Insurance, Dental and Vision Plans – Paid 100% by ICQ
• Shot Term / Long Term Disability – Paid 100% by ICQ
• Life Insurance – Paid 100% by ICQ
• Paid Time off for Holidays, Sick Time and Vacation
• 401 K with a 100% match to the first 4%

GENERAL RESPONSIBILITIES AND REPORTING/EDUCATION/EXPERIENCE
REQUIREMENTS

These positions report to the assigned manager and have responsibilities for development and execution of commissioning and qualification protocols, including test functions, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies. Adherence to timelines and deliverables a must…and much more.
Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:

• 5 to 7 years Cleaning Validation and/or Sterilization
• 5 to 7 years Environmental Monitoring
• 5 to 7 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

RESPONSIBILITIES:

• Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
• BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
• Develop and execute commissioning/validation plans, test plans, validation protocols and procedures.
• Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
• Work as a leader, part of commissioning/validation team, or independently to develop protocols and procedures, execute same including test functions, sampling and calibration.
• Responsible for developing new business opportunities at assigned client sites.
• Communication with management, clients, and project team members.
• Participate in training to ensure continued accreditation.
• Other tasks as required by department management.
• Travel may be required.
• Research and interpret client and vendor-supplied documentation in order to write documents.

OTHER DESIRED SKILLS AND EXPERIENCE

• Process Validation
• Sterilization / Autoclave Performance Qualification
• Quality Systems and Remediation
• Implementation of Quality by Design
• Packaging Line Validation
• Cleaning Validation
• QC Lab Commissioning/Qualification/Validation
• Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
• Strong Attention to Detail
• Proficient at MS Word and MS Excel
• Excellent Communication Skills
• Ability to handle many tasks with limited direction
• Ability to deliver results is a must
• Demonstrated interest in continued professional development
• Demonstrated interest to provide a high level of customer support
• Primavera Scheduler
• CQV Project Managers

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants

It can be disheartening to design and build a new pharmaceutical facility with shiny new stainless steel process vessels and tubing only to see what appears to be rust appearing exactly where you don’t want it. However there is hope and you are not alone. Rouging in process equipment is very common and in some cases is considered quite stable. This blog post will not pretend to present the various chemical reactions in the rouging process. Nor will there be any definitive statement of what course of action a company should take given that each process, effect on product and severity of occurrence is unique.

What causes Rouge?

There are many positions on what causes rouging. One thing that everyone can agree on is that Rouge is a form of Iron Oxide. Yes, this means it is a form of rust, not what you want to hear when you need to assure your process to not be Reactive, Additive or Absorptive to protect product Safety, Identity, Strength, Quality and Purity (SISQP) (CFR21 Subchapter C, Part 211 Subpart D Section 211.65).

Rouge can begin to form on surfaces that have been damaged from cavitation (pumps and turbulent tubing arrangements), dented tubing, impingement (from sprayballs), improper surface Ra (roughness) and from plain old scratching and gouging of surfaces during routine maintenance and processing.

Rouge Classifications

There are three types of rouge;

Class 1:  Limonite, FeO (OH). Rouge that originated outside of the system where it was discovered. This type of rouge can then migrate to the affected system through process streams and more commonly WFI and Clean Steam. This type of rouge is your typical reddish-orange.

Photo Credit: Ateco Tobler AG

Class 2: Hematite, Fe2O3.  This type forms in place, within the affected system.  This can be the result of surface damage within a stainless steel vessel or associated stainless steel tubing.  Hematite is brownish in color.

Class 3: Magnetite, Fe3O4.  This is the type that typically forms in high temperature steam systems.  This class of rouge is blackish in color an can be powdery or glossy.

 

 

Photos Credit: CPP Chemical Plants and Processes

Where to Expect Rouge

For the rouging process to occur you must have water present. This means that high purity water systems often are the source of Class 1 rouge found throughout processing systems. The distributed nature of Water for Injection (WFI) means that rouge can quickly migrate throughout multiple processing areas. Other sources of Class 1 rouge can be improper Material of Construction (MOC) fittings upstream from a system or from improper surface finish such as surfaces with an Arithmetic Average Roughness (Ra) measurement above 15-20 Ra. In some cases a process requires Electro-Polished (EP) surfaces which in conjunction with surface roughness are expressed as RaEP. Electro polishing is a process by which the “peaks” of a surface are removed through the use of an electric current and electrolyte. This provides a surface that has less surface area for reaction and fewer crevices for migrating rouge to take hold.

Turbulent water flow and cavitation can also damage the surface finish in tubing and pump housings resulting in a surface where the chromium oxide layer has been removed and exposure of the stainless steel surface higher in iron. As could be expected, rouge will form in these situations and this will also find its way into your process vessels.

Class 2 rouge is often the result of a damaged, previously passivated surface. CIP sprayballs can be the culprit in pinpoint rouge spots within a vessel as a result of high flow rates. Often times these spots will occur on the dome of the process vessel where they are not visible from sight glasses. This gives them time to form undetected and it’s not until rainbow-colored streaks of discoloration are noticed making their way down the vessel walls that their presence is discovered.

Photo Credit: Spray Balls by John C. Tverberg March 26, 2012

The air/liquid interface is also a prime location for rouge development as you have air and water, the key contributors. This is something to keep an eye out for in processes that require long wet vessel hold times and for vessels that are held for long periods of time prior to CIP post use and or are left wet post use.

Another scenario can be rouging from a damaged vessel wall or bent process tubing. Bent tubing may not be appear as an immediate concern however when one considers the surface of the tubing inside at the bend point, there could well be a change in the surface character by which underlying stainless steel layers are now exposed along with the higher iron content. A damaged surface example could be when a sight glass is being removed and a nut falls into the vessel and pings around a bit. The bottom outlet is removed and the wayward nut is removed from the vessel. This may seem like the problem is solved however the surface where the nut made impact is most likely damaged and no longer meets the required surface finish specification. An Ra measurement should be obtained or at a minimum this event should be recorded. Doing so will aid in the investigation should rouge begin to appear at the bottom of the vessel. If damage has occurred and the surface is not re-electro polished then pitting can occur that will require more extensive corrective measures such as grinding and filling with 316L rod followed by electropolishing.

Class 3 rouge is common in clean steam systems and less alarming that class 1 or class 2 rouge as it often in the stable form of Magnetite. Unless there is a powdery nature to the rouge, these systems can be operated for years with this rouge present without negatively impacting your process.

Rouge Remediation

Removal of rouge should be decided on a case by case basis. Some companies choose to establish monitoring programs by which the presence of rouge is observed and recorded for any changes in appearance or proliferation. This coupled with quality testing of product can often be sufficient to ensure that the presence of the rouge is not impacting product Safety, Identity, Strength, Quality or Purity.

Another approach has been to aggressively pursue the removal of all visible rouging from process systems. This should only be attempted after thorough investigation including classification of rouge present and best determination of sources. If the sources can be identified, in cases such as improper MOC fittings or pump cavitation due to non-optimal operating parameters, then it goes without saying that these identified causes should be addressed prior to overall system remediation.

Once the path of remediation has been decided on, there is really only one preferred method, Citric Acid Passivation. Other options exist such as Nitric Acid passivation and possibly even manual cleaning coupled with De-rouging CIP cycles. These latter two options have their drawbacks however.

Both Citric and Nitric acid passivation effectively remove surface contaminants from stainless steel and increase the Chromium Oxide to Iron Oxide ratio. However, Nitric Acid passivation can release toxic gases and must be disposed of as hazardous waste. Citric Acid on the other hand is organic and safe to use and does not require that it be treated as hazardous waste. Furthermore, with temperature elevation, Citric acid can accomplish passivation in a shorter period of time while Nitric Acid is more dangerous at high temperatures.

With regards to manual cleaning, this choice is not optimal as it subjects the vessel to possible damage. The process of entering a vessel for manual cleaning can be abrasive to the surface and increase the potential for scratching and gouging. This option is often chosen regardless of the drawbacks when there is substantial rouging that requires removal.

De-Rouging CIP cycles can all be used utilizing higher percentages of acid in the cycle. These ~5% acid cycles have proven to be effective in milder cases of rouging and as part of a preventative rouge program.

Conclusion

Despite our best efforts, rouging is here to stay. Though we decide on differing approaches to how to handle its presence, the fact remains that we can expect to see this uninvited guest in our process equipment and utilities. At least we can take comfort in knowing that this is happening industry wide and we can potentially learn from each other’s efforts.

Written B: Joe Herrick, Managing Consultant

Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in-depth view of what we are all about: http://icqconsultants.com