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nr%V F.T.R. / PM-RESEARCH & DEVELOPMENT CH - 2003 NEUCHATEL / SWITZERLAND INTER - OFFICE CORRESPONDENCE To: D. Schulthess Date: July 19, 1993 From: R. Hofer, D. Parthenopoulos Doc.name: merep.doc Subject: Report of visit to the Middle East Official laboratories. Copies: B. Baroudi, J.-B. Boder, M. Bourlas Visits were paid to the official laboratories of Qatar, Kuwait and Saudi Arabia between June 26 and July 4, 1993. Qatar B. Baroudi, M. Mansour, D. Parthenopoulos and R. Hofer visited the smoking laboratory of the Ministry of Health of Qatar in Doha. This was the first visit after a long time of PME R&D personnel to this laboratory. The purpose of the visit was to meet management and laboratory personnel and to become familiar with the implemented technical procedures and the way ISO standards were applied. It became quickly obvious to us that this laboratory has a peculiar interpretation of ISO standards. The information we gathered is: A) Equipment: one Filtrona 8 port linear smoking machine SM 302 fitted with an ATCOM (not in use). There is no adequate conditioning room or cupboard. Cigarettes are equilibrated in the smoking laboratory conditioned for "comfort" (ca. 28 °C and 70 % RH). Smoke nicotine (SN) is determined by GC, water is not determined on a regular basis. In the GC determination of SN the external standard method is used and heights of peaks are compared (no integrator was available for the SN determination). B) Sampling: 5 packs per brand are normally sampled for one analytical result. 25 cigarettes from these 5 packs are then prepared. They do not analyse all the brands, it seems they keep track of historical data and only test new brands and those which were found out of tolerances. C) Smoking: 6 channels are dedicated to the cigarettes of one given brand, 2 channels are reserved for a monitor cigarette (ex BAT from what we could see). Only 3 cigarettes are smoked on each channel. The filter holders are then weighed and TPM is calculated. After that, each filter is individually extracted and SN is determined by GC. The result for a brand

2 consist of a triplicate measurement (a total of 54 cigarettes per brand are thus smoked). Tar numbers are estimated by means of a correlation between TPM and SN values. D) Compliance: If the analytical result for SN is below 0.8 mg/cig (tar is probably never directly calculated and therefore not taken into account), the brand is cleared. If the result exceeds the 0.8 mg/cig limit, another sample (of 54 cigarettes) is analysed. The importer receives a warning if that second analysis exceeds again the limit. If in a subsequent analysis, the brand exceeds again the limit, the goods are blocked. E) Tolerances: None. They regard nicotine as a poison and, similarly to heavy metals in drinking water, its concentration cannot exceed a given amount (0.8 mg/cig). When we addressed the tolerance issue and the fact that a cigarette is a natural product which could not always be produced at 0.8 mg SN and 12 mg Tar, we were told that our production specifications should be set such as to target below 0.8 and 12 mg/cig. F) Revised ISO Standards: We presented the newest Standards as allowing more reliable and consistent results. Dr. Khalifah Al Jaber, the head of that section, asked following our visit of the laboratory whether any changes could be introduced to improve the laboratory (but not to our advantage as he pointed out). We replied that an adequate AC was needed since it has a direct impact on yields, that the SM should be up-graded and that a GC should be dedicated to the determination of water and SN. Dr. AI Jaber also asked whether there was a correlation between smoke yields and relative humidity and temperature. He was answered that each type of blend had its own behaviour and that therefore, there was no simple solution to the conditioning situation of the laboratory. Conclusion: That laboratory is by far not applying correctly the ISO standards and many efforts should be invested to bring it to a decent standard. On the other hand, why not leave it in this state, since their analytical results have not harmed our products for the past years_ Kuwait The two major purposes of our visit to the smoking laboratory of the Ministry of Public Health in Kuwait were to raise the issue of the implementation of minimum tolerances for Tar (1 mg/cig) and smoke nicotine (0.1 mg/cig) as recommended by ISO 8243 as well as to offer technical assistance with the nicotine and water gas chromatographic analyses. Regarding the tolerances issue, the arguments which were invoked were well received and we are confident that they will be applied in the future. We would appreciate it if B. Baroudi could obtain, in a forthcoming visit, confirmation in writing. In the course of our discussions, we were told that 50 to 100 cigarettes per brand are smoked from an initial sample of 2 to 4 cartons. Due to the limited shaker capacity, only 4 to 8 filter pads are extracted and analysed for water and smoke nicotine. Mrs Maarafie informed us that the manufacturer of Cleopatra, with which she experienced many problems regarding deliveries, had finally sent a sample to the LGC laboratory. We explained that the PME R&D smoking laboratory would soon be accredited and proposed to run, once in a while, between the two laboratories, a collaborative test on PM brands. This would give even more credibility to the results of the Kuwaiti laboratory. She accepted the proposition. Regarding the implementation of new ISO standards, we were told that the capital

3 investment request will be added to the present budget. B. Baroudi proposed to help her justifying the project, which was accepted. The GC BASIC programme in use at PME R&D was extensively modified in order to be able to utilise it on the new model of integrators supplied by Hewllet Packard to the Kuwaiti laboratory. This new version of the programme was installed in Kuwait and the laboratory personnel was trained on it. Tentative arrangements were made for further training the laboratory supervisor Mrs. F. Hassan in Neuchatel at the end of August. Conclusion: The laboratory personnel are cooperative. Additionally they are technically skilled and are capable of doing good analytical work, provided they have the necessary equipment. Saudi Arabia The purpose of the visit was to monitor the status of the laboratory as well as to observe the implementation of the new ISO standards following the training received in Neuchatel by the SASO chemists. After last year's visit, a letter recommending some maintenance actions for the HVAC had been sent to the director of SASO laboratories, Mr. Saad Al Hussainan. During the welcome discussion, he informed us that several parts, mentioned in my letter, had to be replaced after they failed. These failures prevented the laboratory from performing any analyses since temperature (T) and relative humidity (RH) could not be controlled anymore. The major consequence is that the two chemists could not practice the acquired skills of revised ISO smoking. We were also told that a additional chemist would work in the smoking laboratory, namely Mr. Abdulla Alattas who recently joined SASO. When entering the smoking laboratory, it was immediately noticed that T and RH were outside the ISO tolerances. Appropriate adjustments and maintenance were made in order to bring the laboratory atmosphere under control. After that, a brand, including 4 monitor IM-14 positions, was analysed. The TPM values of the monitor cigarette indicated that the air flow was far too high. Air velocity measurements confirmed this and we then adjusted the smoking machine air flow to the prescribed ISO specifications. The importance of maintenance was stated again to SASO laboratory management. We were told that SASO is not in favor of signing maintenance contracts. As a result they often experience problems with the GC as well as the HVAC system. Minor maintenance was performed on both the GC and the HVAC system. It is clear that the HVAC system has been in use for several years and that now it is time to go though a major inspection and perhaps readjustment of the electronics and other hardware if we would like to ascertain proper functioning in the coming years. The SASO database that was developed at PME R&D was installed on the PC and the laboratory personnel was trained on its use. It was explained to SASO laboratory management that the database can be very useful in firstly keeping track of suspect brands and secondly improving the organisation of the laboratory's analytical work, provided it is used properly. It was also suggested that only results obtained with the revised ISO method be entered in the database in order to avoid confusion with old results (obtained using old

4 ISO). By discussing with the laboratory personnel, we gathered that: - PM brands have not been analysed in the past 6 to 12 months, old analytical results are sent to customs. - Hope menthol was blocked three times before complying with the limits of 12 and 0.8 mg/cig. - Now that the revised ISO standards are implemented, SASO will again test all the brands available on the market. Since there are over a 110 brands, this make take a certain time! Conclusion: Minimum (corrective) maintenance is performed at SASO. If PM would like to ensure proper functioning of the SASO laboratory, a one-time maintenance of the HVAC should be offered to SASO. In addition a maintenance contract for the GC would be helpful. Finally on-site technical assistance should be continued as well as training of new SASO laboratory personnel (high-turnover) by PM. Product Quality Audit R. Hofer D. Parthenopoulos .0