/ By Panorama Consulting & Engineering Inc. / Chemical Industry • HAZOP • Pharmaceutical Industry/ 0 Comments

HAZOP Analysis For Chemical Process Industries

“An ounce of prevention is worth a pound of cure.” As this old saying goes, safety should be an important element in every industry. Safety covers hazard identification, risk assessment and accident prevention. Safety should always come first and remain so despite of costs. Good design and forethought can often bring increased safety at less cost.

Operators of volatile plants must implement measures to ensure that their plants are operated and maintained in a safe manner. In the chemical process industry there are chances of a number of potential hazards. A hazard has the potential of causing an injury or damage to the plant as well as the working members. Raw material and intermediate toxicity and reactivity, energy release from chemical reactions, hightemperatures, high pressures, quantity of material used etc. are some of the hazards that can cause damage in a chemical industry plant.

HAZOP refers to Hazard and Operability studies. HAZOP is a systematic technique for examining potential hazards in the system. With HAZOP, the process is broken down into steps where every parameter is considered to see what could go wrong and where. This is the most common hazard analysis method for complex systems. It can be used to identify problems even during the early stages of project development, as well as identifying potential hazards in existing systems.

An important benefit of the HAZOP study is resulting knowledge that can be of great assistance in determining appropriate remedial measures. There are four steps to the HAZOP process:

  • Forming a HAZOP team:
    A multidisciplinary team is formed under the guidance of a leader. The team includes a variety of expertise such as operations, maintenance, instrumentation, engineering/process design, and other specialists as needed. The fundamental requirement is an understanding of the system and willingness to consider various parameters at each step of the process.
  • Identifying the elements of the system:
    The team must create a strategic plan for the entire process identifying individual steps and elements. This typically involves using a plant model as a guide for examining every section and component of the process. For each element, the team will identify the planned operating parameters of the system at that point: flow rate, pressure, temperature, vibration, and so on.
  • Considering possible variations in operating parameters:
    The team must be open to the idea of considering every possible variation to the parameters identified. Every deviation should be studied and potential hazards to be identified for each scenario.
  • Identifying any hazards or failure points:
    Once the team has identified potential hazards, they must estimate the impact of that failure. Existing systems should be evaluated and their ability to handle deviations in the future must be taken into consideration.

The overall aims to which any HAZOP Study should be addressed are:

  • To identify all deviations from the way the design intended to work, their causes and all the hazards and operability problems associated with these deviations.
  • To decide whether action is required to control the hazard or the operability problem, and if so, to identify the ways in which the problems can be solved.
  • To identify cases where a decision cannot be taken immediately and to decide on what information or action is required.
  • To ensure actions decided are followed through.

HAZOP studies can be implemented for new facilities or existing facilities or processes. When a HAZOP study is performed in the planning stage of a new process, completing the study means that all potential causes of failure will be identified.Whereas in existing facilities,instead of one assessment, the results will be released as each problem is identified and solutions are created.

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Process Validation for Pharmaceutical Industry

For the Pharmaceutical industry, validation of processes and equipment is crucial; while the FDA doesn’t necessarily demand one, documented evidence should prove to overcome future mishaps. A Validation Master Plan is a document that outlines the areas and systems that require validation, risk assessment and their consistency in the long run. A VMP is essentially useful during audits as it lays down the strategies implemented by the facility.

Standard Operating Procedures (SOPs), production formulas, detailed documentation batch change Control, experimental reporting systems, analytical documents, reports development, validation protocols and reports are an integral part of validation philosophy.

The documentation provides information related to the ongoing operation of the plant and is used for development or modifications. Validation happens at various levels and is of different types.

Prospective validation

As the term suggests, prospective validation is a pre-planned process. This validation is carried out during the development stage Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. After which an overall assessment is made; if the results are favorable, the process is satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale, e.g. in the preparation of injectable products.

Concurrent validation
Concurrent validation occurs at the normal stage. This validation establishes that a facility and process will perform as they are intended, based on information generated during actual use of the process. It defines how the product will be managed throughout the process. Concurrent validation process is identical to prospective validation.

Retrospective Validation

Retrospective validation is done on systems that have been operating for a while. Generally during this type of validation, a complete validation process isn’t required. Doing a full validation may not be required; since there is proof that the system functions are as required. However, doing nothing may be a risk. Historical data can certainly be used to support validation.
During retrospective validation, it’s advisable that the product be separated and production should be put on hold until the validation process has been completed.

Revalidation

Revalidation is needed to ensure that changes in the process product quality. Revalidation may be divided into two broad categories:

  • Revalidation after any change bearing on product quality.
    Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure bearing on the established product performance characteristics. Every such change requested should be reviewed by a qualified validation group, which will decide whether it is significant enough to justify revalidation and, if so, its extent.
  • Periodic revalidation carried out at scheduled intervals
    Process changes may occur gradually even if experienced operators work correctly according to established methods. Equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.

Before process validation can be started, manufacturing equipment and control instruments must be qualified. All aspects of manufacturing must be validated, including critical services (water, air, nitrogen, power supply, etc.), and supporting operations, such as equipment cleaning and sanitation of premises. Proper training and motivation of personnel are prerequisites to successful validation.

/ By Panorama Consulting & Engineering Inc. / Chemical Industry • Construction Management • Pharmaceutical Industry • Project Management/ 0 Comments

Signs your construction project is headed towards failure

Chemical and Pharmaceutical Plant Construction projects involve high risks and heavy investments. Sometimes a single risk can manage to blowout your project. At other times, a combination of risks will be the reason for your project failure. One or multiple, either can prove to be fatal for the project and company. It is critical to identify project failure sooner and devise solutions before the risks escalate.

Here’s a list of obstacles that could lead to project failure and solutions on how to overcome them.

  1. Schedule overdue – Scheduling is the first step one takes when working on any project. For any successful project, scheduling needs to be on track. Once the train is off track, your project is bound to suffer. Project leaders must ensure that every schedule is being followed devotedly. In case work deviates from the track immediate measures must be taken to cover for lost time.
  2. Team mismanagement – For a project, the team comprises of experts from varied fields. Architects, maintenance engineers, owners, electricians, plumbers etc. are few of the people that work together on the project. Disagreements and conflicting ideas lead to setbacks in your project. The most effective way to handle these holdups is to evaluate ideas and execute the strategies that are most effective.Project management services should be implemented after thorough analysis.
  3. Budget – While being on schedule is important, managing to be on the stipulated budget is imperative. Spending over the budget can lead to major dents in the financial plan. Project leaders must always be on their toes especially when the budget is skirting towards the warning line.Costs for construction projects are high and involve a lot of risks.
  4. Poor communication – Any project is likely to fail with poor communication. Generally, lower level employees are hesitant to report to upper level management leading to delay in project work. Upper level managers consider it irrelevant to inform employees at the lower level. Communication amongst all levels is vital to ensure that the project is functioning smoothly. The project leader should act as the communicator link between all levels.
  5. Inconsistent management – Project leaders must avoid inconsistency in decision making. When minor plans keep changing course, it will be difficult to meet the goals in time. Leaders have to be firm in their decision-making and must have a foresight for the future. Project management services should be implemented to ensure the success of a construction project.

Every project, no matter how big or small, will face problems at every stage. Good leadership and communication is the glue that will stick your project together in times of failure. A healthy working environment for the employees and strategic approach aid in the long run.
Panorama provides complete project management services right from planning to execution. Every step is supervised under the watchful eyes of experts in the field. With Panorama, your construction project is far from the trenches of failure.

/ By Panorama Consulting & Engineering Inc. / Pharmaceutical Industry/ 0 Comments

Pharma Validation Services

All Pharma validation services companies provide a comprehensive validation service at every stage of the project life cycle. These companies assist with all aspects of validation relating to equipment, facilities, GMP utilities and computer systems. Pharma validation services ensures support to clients in developing, implementing and achieving a validation strategy and programme that is designed to meet the customers’ timescales and budget whilst fully satisfying the cGMP requirements and the regulatory obligations of the licensing bodies.

It begins from the design stages of a project i.e. during User Requirement Specification (URS) development, Design Reviews right through Vendor Factory Acceptance Testing (FAT) to site Commissioning, Installation Verification and Qualification (IQ), Operational Testing and Qualification (OQ) and Performance Qualification (PQ).

Pharma validation services typically include:

  • Validation Master Plans / Validation Plans.
  • Design Qualification.
  • Design Reviews Support.
  • Computer Systems Report.
  • Installation Qualification (IQ) Protocols.
  • Site Validation Execution.
  • Operation Qualification (OQ) Protocols.
  • Final Validation Summery Reports.
  • Performance Qualification (PQ) Protocols.
  • Cleaning / Sanitation Validation Protocols.

All projects should be delivered by the engineering company with a precise level of Project Management, Scheduling and Cost Control Metrics to monitor progression.

The engineering company providing Pharma validation services has to carefully plan the entire process cycle of the project. The guiding document on qualification & validation of the object has to be the Validation master plan. Along with the technical expertise, the pharma validation services company cannot ignore the importance of including several specialists i.e. technologists, engineers, metrologists etc.

Qualification & Validation Areas of Pharma companies:
The qualification phase pertains to actions given how a specific equipment gives the expected results & works properly.

Qualification stages:

  • Design qualification
  • Installation qualification
  • Operation qualification
  • Performance qualification

Validation stages:

Validation phase relates to actions that in accordance with the principles of good manufacturing practice prove that a specific method, approach, process, equipment etc gives the expected results.

Validation services:

  • Validation of sterilization process
  • Media fills
  • Process validation
  • Cleaning validation
  • Validation of the cold chain
  • Validation of the monitoring, the automated control systems

List of activities:

Typical pharma validation services companies prepare the following reports:

Production premises:

  • Clean rooms
  • Isolators & other barrier systems
  • HVAC systems

Sterilization:

  • Steam sterilization
  • Dry heat sterilization
  • Ethylene oxide sterilization
  • Formaldehyde sterilization
  • Depyrogenation
  • SIP systems

Washing & Cleaning processes:

  • CIP systems
  • Primary packaging & Auxiliary materials washing
  • Cleaning validation

Pure media

  • Water for injection
  • Highly purified water
  • Clean steam
  • Compressed air, nitrogen & other gases

Other production processes / Production of equipments:

  • Preparation of solutions, ointment bases
  • Dry powder filling
  • Lyophilization
  • Decontamination of external surfaces
  • Optical control
  • Granulation
  • Homogenization
  • Tableting, coating, capsule filling
  • Blister packaging
  • Cartoner, group packaging
  • Labelling
  • Cross contamination
  • Process validation

Sampling zones / Warehouses:

  • Clean rooms
  • HVAC
  • Direct air flow zones
  • Special storage conditions chamber
  • Validation of cold chain processes

Monitored, automated control systems:

  • Production premises
  • Pure media
  • Production equipment
  • Production processes
  • Production storage & warehousing

Laboratories, hospitals, clinics, pharmacies etc.

  • Clean rooms
  • HVAC systems
  • Laminar boxes, isolators, biological safety cabinets
  • Thermostats, incubators, refrigerators, freezers
  • Stabilization boxes
  • Sterilization & depryogenation processes
  • Washing, cleaning & Decontamination processes

It’s a simple question, not always the easiest to answer. Which could be the best pharma validation services company? How to evaluate? Panorama’s pharmaceutical compliance and validation services combined with pharmaceutical consultancy services are all aimed at making this an easier question to answer.