Industry Blog

Vacancy - Design Engineer

Hanningfield are a British engineering company who specialise in the design and manufacture of world-class machines for the pharmaceutical, food, chemical and associated industries.

We are looking for a talented engineer to join our design team, with a view to an immediate start.

 

Responsibilities

Creating general arrangement drawings, detailed manufacturing drawings, P&ID drawings.

Capable of conceptual mechanical design, including bespoke product design.

Creating Functional Design Specification (FDS) documents.

Creating Factory Acceptance Test (FAT) documents.

Capable of performing stress calculations, stress analysis, load calculations etc.

Creating standard test protocols for machines.

Creating Bill of Materials.

Creating recommended spares lists.

 

Requirements

Preferably degree qualified in an engineering-related subject (such as Mechanical Engineering, Design Engineering etc).

You should have a wealth of experience with 2D and 3D CAD, specifically AutoCad and Solidworks.

An in-depth knowledge of the engineering standards required by the pharmaceutical industry would be an advantage.

You must be highly analytical, with excellent attention to detail.

Outstanding personnel skills.

 

To apply, please e-mail your CV and covering letter to careers@hanningfield.com.

Uni-Dust Cyclone in Action

The loss of excess powder from compression and filling machines is one of the major problems in powder processing. Often, powder passing to the central extraction system wil cause downstream filters to block or a dangerous mix of powders to form in the central system itself. If filters blind they can be expensive and time-consuming to replace.

Hanningfield’s solution takes the form of a filterless recovery cyclone - the ‘Uni-Dust’. The cyclone can be fitted (or retrofitted) between the compression/filling machine and the LEV line inside the process room. The cyclone then separates the dense powder particles from the air, allowing clean air to pass down the LEV line and the solid powder material to be collected in a capture-pot at the base of the cyclone, ready for batch loss reconciliation. This capture-pot is also available with a safe-change facility to protect operators.

The Hanningfield Uni-Dust cyclone offers a best-practice solution to the problem of handling excess powder, with typical capture rates of over 95% on most pharmaceutical and food powders.

We are able to offer free trials on your powder at our UK Test Facility. If you are interested in testing your material on our cyclone, simply contact us.

Hanningfield ‘Table-Top’ Stand at 2011 ISPE UK Conference

Following the success of last year, Hanningfield will be exhibitng at the ISPE UK Affiliate Conference in Liverpool, UK, on 24th November 2011.

Last year presented an excellent opportunity to meet with industry professionals and experts, and to discuss many of the current trends affecting pharmaceutical processing.

If you are attending the conference, we would be pleased to meet you.  Just look out for our stand (pictured below).

Conveying of Tablets and Capsules

Overcoming the Problems of Tablet and Capsule Transfer

It is commonly acknowledged that extreme care must be taken when attempting to transport tablets and capsules from one process to another by whatever means used. The fragile nature or these products means damage can easily occur during the transport stage thus potentially wasting valuable finished goods.

Tablet and capsule handling systems must be carefully designed to avoid damage or breakages

Popular methods used for the transfer of these products are vacuum, gravity, and air all of which are standard practice within the pharmaceutical and associated industries. Hanningfield can offer much experience in this area but several points must be taken into consideration to achieve efficient material handling without damage to the finished product.

 

Design

Special attention has to be taken regarding design and construction materials to avoid damage to the finished product. Using specially developed design techniques it is possible to adapt standard Hanningfield process equipment to suit this highly specialised yet popular application.

For example, removable silicone liners can be supplied to fit inside vacuum transfer hoppers to avoid contact between the tablet and any metal surfaces. Specially designed air flow control valves can also be fitted to ensure when vacuum conveying of tablets, they can only move in one direction during vertical transfer cycles.

 

Methods

Vacuum Transfer is a well established process that can be adapted to efficiently convey coated and uncoated tablets very successfully. Internal surfaces must be specially designed to ensure the tablets do not come into contact with sharp edges or corners during transfer (‘step-less conveying’). Other precautions are taken to ensure tablets will only move in one direction during transfer by use of a specially design uni-directional flow valve. The Hanningfield uni-vac system offers a number of enhanced capabilities that combine to provide safe effective tablet transfer without compromising the finished product.

Gravity is the simplest and most common transfer technique for the efficient transfer of tablets and capsules. This process is however limited to a vertical or near vertical flow path only, whereas vacuum and air powered systems can transport across horizontal distances as well as vertically upwards. To control tablet transfer, Hanningfield can supply a special flexible vane butterfly valve to minimise risk of damage when opening and closing the valve.

Air (positive pressure) is used by Hanningfield for the efficient transfer of both empty and filled hard shell capsules. Capsules are less likely to suffer from damage than tablets during conveying but internal conveying pipes must be smooth bore without ledges and sharp corners as with vacuum conveying. The positive pressure system provides a high flow, low pressure air cushion that gently moves the capsules through the convey pipe-work. Static is a common problem with capsule transfer so any system design for this application must provide an anti-static design.

 

Summary

In addition to good and efficient design, experience is also necessary to ensure all aspects of product protection are taken care of. This is where Hanningfield can provide the necessary input at the system concept stage to ensure a successful project conclusion using our highly skilled team of experienced engineers to guide the customer every step of the way.

GMP (Good Manufacturing Practice) Explained

A Technical Article by Colin Ellis (Managing Director, Hanningfield)


What is GMP?

GMP or ‘Good Manufacturing Practice’ is the area of quality assurance which ensures that medicinal (and some food) products are consistently produced and controlled to the quality standards appropriate for their intended use and as required by the product specification. In this respect, GMP is concerned with both quality control and production.

“The FDA inspects manufacturing facilities worldwide using scientifically and cGMP-trained individuals whose job it is to evaluate whether the company is following the cGMP regulations.” GMP regulations are enforceable by law and require that manufacturers, processors, and packagers of pharmaceuticals, medical devices, and some types of food products take proactive steps to ensure that their products are pure, effective and safe to use.

"The FDA ensures cGMP standards are upheld."

GMP regulations address all issues that concern record keeping, hygiene, personnel qualifications, cleanliness, equipment verification and the handling of complaints. These regulations in turn protect the consumer from purchasing a product which is ineffective or potentially life threatening. Failure of manufacturers to comply with GMP regulations can result in very serious consequences such as seizure, recall, fines and ultimately imprisonment.

The main aim of GMP is to consistently produce high quality medicines or medical devices that meet the international standards required for responsibly managed healthcare. Processes used in manufacture are carefully controlled, and any changes to the process must be evaluated. Changes that have an impact on the quality of the finished product are also validated as required and checked for compliance and consistency with the product specifications.

GMP requirements are not definitive instructions on how to manufacture specific products. GMP forms a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways to comply with GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is sometimes referred to as ‘cGMP’ or ‘Current GMP’ reminding manufacturers that they must employ technologies and systems which are up to date in order to comply with the relevant regulations. Systems and equipment adopted to prevent contamination and errors in the past may be considered less than adequate by current standards.


The Basic Rules of GMP

• Operators must be adequately trained to carry out and document procedures.

• Instructions and procedures should be written in clear and unambiguous language. These instructions are often referred to as ‘SOP’s’ or ‘Standard Operating Procedures’.

• Records must be kept, (manually or by instrumentation), during manufacture which proves that all the steps required by the defined procedures and instructions were taken and that the quantity and quality of the drug was as expected.

GMP is as much about procedures and operator training, as it is about equipment usage.

"GMP is as much about procedures and operator training, as it is about equipment usage."

• Any deviations from the standard procedure found during the keeping of production records must be investigated and documented.

• Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be kept and retained in a comprehensible and readily accessible form.

• Care must be taken to ensure the distribution of the drugs minimizes any risk to their quality.

• A system must be in place for recalling any batch of drug from sale or supply.

• Complaints about marketed drugs must be examined and the causes of quality defects investigated.

• Appropriate measures must be taken with respect to the recall of defective drugs to prevent any future recurrence.


Equipment Design and Manufacture

GMP also applies to the design and manufacture of process equipment. Although this area of GMP is not strictly covered by legislation, it is the responsibility of the equipment manufacturer to understand the importance of hygienic design and the training of competent staff to design and construct equipment that meets the specific needs of the end user and comply with GMP requirements. Documentation also has to be provided to give evidence of competence and materials used in construction.

GMP also applies to equipment manufacture

"GMP also applies to equipment manufacture"

The following points should be considered in the design and construction of process equipment intended for use in GMP regulated industries;

• Design must avoid where possible ledges, dirt traps and flat surfaces where excess dust layers can build up.

• All equipment should be easy to clean and ideally be dismantled without the use of tools.

• Materials of construction must meet the required specification and evidence of materials used should be available. In some cases thorough traceability may be required through mill certificates or other means of identification.

In general most end users will provide a detailed specification or URS (user requirement specification) which will provide in detail the exact requirements in terms of materials, surface finishes and material certification. Competency of the manufacturers ability is also often required which may include evidence of a recognised quality system and proof of staff competency for areas such as design, welding, electrical and other areas of equipment construction.

Hopefully this has helped to shed some light on GMP. If you have any questions whatsoever, I would be delighted to answer them.


Colin Ellis

About the Author

Colin Ellis is the Managing Director of Hanningfield. He has over 30 years experience in the process industries.

Prior to founding Hanningfield in 1987, Colin worked as an engineer for Smith and Nephew, May and Baker and GlaxoSmithKline.

E-Mail: colin@hanningfield.com

Lump Breaker

Features

• Stainless steel construction
• Low maintenance, easy-clean design
• Compact Size
• Low mounting space
• External outbound bearings
• ATEX Versions available

Technical Specification

• Throughput: Up to 10,000 kgs/hr
• Inlet dimensions: 450mm x 550mm
• Motor Power: 2.2kW

Colin Ellis

Product Profile

The size reduction of agglomerated bulk material is imperative to the success of various processes such as milling and sieving. The SureBreak disperses large particles reducing the strain on downstream process equipment, enabling efficient operation without overloading. Moreover, pre-breaking is ideal for size reduction into machines with inlets too small to accept material in large pieces.

The SureBreak lumpbreaker features either single or double shafts with rotating breaker-arms. The breaker arms cross mesh with stationary breaker bars mounted on the inside of the lump breaker machine.

The SureBreak lump breaker is a low speed machine that reduces the product by a cutting and sheering action. Furthermore, no grinding takes place during the size reduction process, resulting in no heat generation, less noise and no metal-to-metal contact.

Agglomerated material is fed into the SureBreak and is forced between the breaker arms where it is crushed into smaller particles. By selection of the number and size of breakers, it is possible to select a suitable finished product. The SureBreak can be used for a variety of applications across the pharmaceutical, food, chemical and associated industries.

The lump breaker is designed and manufactured by Hanningfield in the United Kingdom.

Pharmaceutical Powder Loading

The loading of machines with powder can be a complicated and troublesome process.

The biggest issue is nearly always containment. How do you ensure that no powder is leaked or lost during the transfer?

A common problem occurs during the loading of tablet presses, granulators, high-shear mixer, capsule filling machines etc. Often these are loaded from IBCs in the room above the process room. The difficult part is ensuring the powder transfers from the IBC to the machine without any mishaps.  There are a number of ways to achieve a solution including utilising a rotary valve for controlling the flow of powder, or an interlock system between feed chute and IBC outlet.

An alternative problem maybe loading a machine that is on the same floor as the IBC.  How do you transfer the powder from the IBC, into the machine, without spilling or losing powder? In this scenario vacuum transfer is an excellent method of overcoming this problem.

Hanningfield have more than 20 years experience in pharmaceutical processing and have helped numerous manufacturers to solve this problem.  All our equipment is manufactured by ourselves in the United Kingdom. Although each application is different, each objective is the same - to load powder into the machine without any issues.

For more information on how to solve this problem, please just contact us.


Technical Article: Explosive Dust Control

By Christopher Birch (Technical Sales Engineer, Hanningfield)


Introduction

The control of hazardous and explosive environments and substances is a duty of practically every organisation from manufacturing to education. The dangers associated with flammable, toxic and explosive substances such as wood, solvents or fuels are universally well understood and controls are carefully applied. The management and control of dust is perhaps less well understood despite the critical and catastrophic potential hazard.

Between the years 1980 and 2008, there have been 350 serious dust explosions in US factories killing 133 people and injuring many more. In 2003, in North Carolina, 6 people lost their lives due to a tragic dust explosion at West Pharmaceutical Services.

Dust build up is progressive and often occurs out of plain sight in ceiling voids, on top of machinery or in dust collection systems and their filters. Materials that are not normally considered flammable are often lethal as a dust, this includes most metals and other none flammable solids. In the Pharmaceutical industry the problem is compounded further by a general trend towards NANO scale high potency Active Pharmaceutical Ingredients (API’s) which are extremely toxic and because of their small size can be even more explosive.

Why is dust an explosive hazard?
Dusts have a very large surface area compared to their mass. Burning of solids or liquids can only occur at the surface, where it reacts with oxygen, dust particles are very small but have a high surface area. For example, a 1kg sphere of a material with a density of 1g/cm3 would be about 27 cm across and have a surface area of 0.23 m². However, if that sphere was broken down into spherical dust particles of 50µm in diameter (about the size of flour particles) it would have a surface area of 60 m²!

This greatly increased surface area allows the material to burn much faster, and the extremely small mass of each particle allows it to catch on fire with much less energy than the bulk material as there is no heat loss to conduction within the material. When a dust and air mixture explodes, especially in a confined space such as a silo or warehouse, a significant increase in pressure is created, often more than sufficient to demolish the structure.

There are five necessary conditions for a dust explosion or deflagration:

1. Fuel; presence of a combustible dust.
2. Ignition; there is an ignition source.
3. Dispersion; the dust is suspended in the air at a high concentration (LEL see below).
4. Confinement; the dust is confined.
5. Oxygen; there is an oxidant (typically atmospheric oxygen).

Sources of ignition:

• Electrostatic discharge (common),
• Friction,
• Arcing from machinery or other equipment,
• Hot surfaces, overheated bearings,
• Fire

Mechanism of Dust Explosions
Dust explosions are classified as being either primary or secondary in nature. Primary dust explosions occur inside process plant or similar enclosures and are generally controlled by pressure relief through purpose-built ducting to atmosphere. Secondary dust explosions are the result of dust accumulation inside the factory being disturbed and ignited by the primary explosion, resulting in a much more dangerous uncontrolled explosion inside the workplace. Historically, fatalities from dust explosions have largely been the result of secondary dust explosions.

What is special about dust explosions?

There are a few aspects of dust explosions that make such explosions special. When a flammable dust cloud is created, the dust particles are suspended in air, either because it falls from a height or because a blast of air raises the dust from a surface. Since dust is heavier than air, this will only last as long as the force that created the cloud is present. Some finer particles may remain suspended in air while the larger particles settle. Once settled the dust cloud can be raised again to form another flammable dust cloud.

This is different from gases and vapours that, once dispersed to below the lower flammable limit, cannot form an explosive mixture again.  This capacity to be re-suspended has its most serious consequences when a small explosion whirls up the dust deposits in the plant and then ignites the cloud. These secondary dust explosions are the reason why some plants have been destroyed virtually completely.

Another special aspect of dust explosions is that dust deposits can be ignited, for example, due to self-heating, or because the dust sits on a hot surface. A smouldering or burning dust deposit can be an ignition source for any dust cloud that is generated. Alternatively, the deposit may burn, causing fire damage.

Concentrations
Below a certain value, the Lower Explosive Limit (LEL), there is simply insufficient dust to support the combustion at the rate required for an explosion. A figure 20% lower than the LEL is considered safe. Similarly, if the fuel/air ratio increases above the upper explosive limit there is insufficient oxidant to permit combustion to continue at the necessary rate.

Classifying hazardous areas into zones - HSE Guidance
Once an area has been identified as hazardous it should be classified into zones based on the frequency and persistence of the potentially explosive atmosphere. This then determines the controls needed on potential sources of ignition in that area. These controls apply to fixed and mobile equipment, electrostatic discharges and other sources of ignition that maybe brought into the area, such as matches or lighters.

The international standard, BS EN 61241/3, published in 2002 explains the basic principles of area classification for dust hazards. This standard forms a suitable basis for assessing the extent and type of zone, and can be used as a guide to complying with the requirements of DSEAR. Site specific factors should always be taken into account.

Under ATEX regulations, hazardous areas for explosive dust atmospheres are classified into three zones:

1. Zone 20 is an area in which an explosive atmosphere, in the form of a cloud of combustible dust, is present continuously, for long periods or frequently.
2. Zone 21 is an area in which an explosive atmosphere, in the form of a cloud of combustible dust, is likely to occasionally occur in normal operation.
3. Zone 22 is an area in which an explosive atmosphere, in the form of a cloud of combustible dust, is not likely to occur in normal operation but, if it does occur, will persist for a short period.

On 6 April 2008, the Corporate Manslaughter and Corporate Homicide Act 2007 came into force in the UK, which means companies could face severe fines or even imprisonment should a dust explosion occur.
Marking of equipment.

A standardised scheme is used to identify equipment suitable for a specific area. Equipment will carry the explosion protection symbol “Ex” in a hexagon, the equipment category number (1, 2 or 3), the letter G and or D depending on whether it’s intended for a gas or dust atmosphere and other essential safety information. In many cases this will include a temperature rating expressed as a “T” marking and sometimes a gas group. These indicate limitations to safe use.

Protection and Mitigation from dust explosions
Much research has been carried out in Europe and elsewhere to understand how to control these dangers, but explosions still occur. Increased awareness of the problem and the requirement to perform systematic risk assessments of all operations will lead to identification of hazardous situations and many should be eliminated before an explosion can occur. Good housekeeping practices and operating procedures should be used to prevent the build up of dust.

The alternatives for making processes and plants safer depend on the industry. Some industries exclude air from dust-raising processes, known as “Inerting”. Typically this uses nitrogen, carbon dioxide or argon, which are incombustible gases and thereby inhibit combustion. The same method is also used in large storage tanks where inflammable vapours can accumulate. Usage of oxygen-free gases, however, carries a risk of asphyxiation of the operator.

Other traditional methods are used to accommodate primary dust explosions in process machinery. These include 10 barg explosion arrest valves and sealed, positively pressurised control panels. Increasingly dust extraction is used to protect workers from exposure. Dust filters not only collect all the fine dust from the plant, they also create dust clouds during their cleaning or maintenance, so in effect the problem is simply moved from one location to another.

In the pharmaceutical industry this issue of cleaning and emptying dust collection systems is made more hazardous when a high potency API is present. Cyclones that remove over 95% of the air entrained dust before it reaches the filter are being used as an effective way to control and capture potentially dangerous excess dust. This method of dust control also helps pharmaceutical companies reconcile lost material as is required by cGMP standards.

Summary
Unlike solvents or explosive gasses, dust does not automatically disperse in the natural environment. Unless removed from areas of build up the risk of dust explosion progressively increases.

Avoidance of dust explosions and their catastrophic effect can be achieved by careful adherence to HSE guidelines and ATEX and DSEAR requirements. Good housekeeping practices enforced by well adopted operating procedures should be used to eliminate the build-up of deposits of combustible dust. Organisations should regularly inspect areas where dust can build up unseen.

Extraction and then capture of excess dust, by cyclone, before that dust can build up in dust filtration systems is an effective control measure in line with cGMP standards.


Company Description
Hanningfield Process Systems is a UK manufacturer of powder containment, powder processing and powder handling equipment. Hanningfield’s range of products include vacuum convey systems, milling and crushing machines, lifts and hoists and the unique Uni-Dust cyclone.

Manufactured in stainless steel, the filterless Uni-Dust cyclone is a hygienic method of capturing excess dust in the controlled environment of the process room. The equipment is designed to be retrofitted to any dust generating plant; process validation is not effected, making it ideal for both new and existing processes. In-line with cGMP the Uni-Dust makes loss reconciliation a simple matter.

The cyclone separates the solids from the clean air, capturing at least 95% excess powder in a collection pot, the air is then passed through a “police” HEPA filter which increases system efficiency to 99.99% before the clean rather than contaminated air flows to the normal dust extraction unit.


Chris Birch

About the Author

Chris Birch is a Technical Sales Engineer at Hanningfield, with 14 years experience working in diverse areas including containment, size reduction and material handling.

Chris is extremely familiar with cGMP, ATEX regulations, process validation, calibration and reference standard hierarchy.

E-Mail: chris.birch@hanningfield.com

Column Hoists

Designed and manufactured in the UK, the Hanningfield Uni-Hoist is a high quality column lift designed for the pharmaceutical, food, chemical and associated industries.

Capable of lifting up to 1500kgs, the hoist is suitable for almost any application and provides both a safe and reliable solution.  Morevover, the hoists boast a hygienic, cGMP design and are manufactured from stainless steel.

 

 

With over 200 built and installed worldwide, the Uni-Hoist has a wide range of applications, notably for the lifting and rotating of IBCs and drums.

For more information on the Uni-Hoist either click here, or click on the link below.

 

Hanningfield on Front Page of EPM Magazine

Hanningfield are pleased to be on the front page of the January/February edition of EPM Magazine.  Hanningfield are prominently featured on the front page of the magazine, with an article about the Uni-Dust cyclone, and how it can be used to collect excess tablet press powder.


To see the editorial simply click the image above, or click here.

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